Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA product classification. Device class 3. Review panel CV.

Classification

Each row is one field of the openFDA record. The grey name is the field’s name in openFDA’s documentation.

Field	Value	Field name
Product code	QZI	product_code
Device name	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	device_name
Device class	3	device_class
Review panel	CV	review_panel
Regulation number	empty	regulation_number
Medical specialty	Unknown	medical_specialty

Source: FDA openFDA, device/classification, product code QZI, as held in ArrHub’s controlled vocabulary with its citation. Public domain (CC0).

PMA records with this code

Every verified record ArrHub holds under the code, newest first.

Decision	Applicant	Device	Record
2026-09-04	Farapulse, Inc.	FARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM); FARASTAR™ Recording System Modul (truncated in the FDA record)	P230030/S024 FDA
2026-08-25	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, (truncated in the FDA record)	P230030/S016 FDA
2026-08-20	Kardium, Inc.	Globe® Catheter Laminated Ribs	P240044/S006 FDA
2026-08-11	ABBOTT MEDICAL	Volt™ PFA Catheter, Sensor Enabled™	P250022/S008 FDA
2026-08-06	Medtronic, Inc.	Sphere-9 Catheter AFR-00001	P240013/S030 FDA
2026-08-06	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System	P230030/S018 FDA
2026-08-04	Medtronic, Inc.	Sphere-9 Catheter and Affera Ablation System	P240013/S029 FDA
2026-07-23	ABBOTT MEDICAL	Current™ PFA Generator – TactiFlex Duo	P250022/S005 FDA
2026-07-10	ABBOTT MEDICAL	Volt™ PFA System	P250022/S006 FDA
2026-07-10	Medtronic, Inc.	HexaGen RF Generator Software and Remote	P240013/S026 FDA
2026-07-10	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System (FARAPULSE)	P230030/S022 FDA
2026-06-30	Biosense Webster, Inc.	VARIPULSE™ Catheter, TRUPULSE™ Generator with Connection Interface Unit (CIU)	P240006/S016 FDA
2026-06-30	Medtronic, Inc.	PulseSelect Pulse Field Ablation (PFA) Catheter	P230017/S011 FDA
2026-06-26	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, (truncated in the FDA record)	P230030/S023 FDA
2026-06-23	Kardium, Inc.	Globe® Catheter and Globe® Pulsed Field System	P240044/S001 FDA
2026-06-22	ABBOTT MEDICAL	VOLT™ PFA CATHETER, SENSOR ENABLED™	P250022/S007 FDA
2026-06-12	Kardium, Inc.	Globe® Catheter; Globe® Pulsed Field System	P240044/S005 FDA
2026-06-05	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, (truncated in the FDA record)	P230030/S021 FDA
2026-05-28	Medtronic, Inc.	Affera Ablation System	P240013/S022 FDA
2026-05-15	Medtronic, Inc.	Sphere-9 Catheter and Affera Ablation System	P240013/S025 FDA
2026-05-13	Medtronic, Inc.	Sphere-9™ Mapping and Ablation Catheter; Tubing Set; Extension Cable	P240013/S027 FDA
2026-05-06	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System	P230030/S019 FDA
2026-04-21	Medtronic, Inc.	Sphere-9 Catheter	P240013/S024 FDA
2026-04-16	ABBOTT MEDICAL	Volt™ PFA System	P250022/S003 FDA
2026-04-13	ABBOTT MEDICAL	Volt™ PFA Catheter, Sensor Enabled™	P250022/S004 FDA
2026-04-13	Medtronic, Inc.	PulseSelect Pulse Field Ablation (PFA) Catheter	P230017/S010 FDA
2026-04-02	Medtronic, Inc.	Sphere-9 Catheter; Tubing Set; Extension Cable	P240013/S023 FDA
2026-03-23	ABBOTT MEDICAL	Volt PFA Catheter Sensor Enabled™	P250022/S001 FDA
2026-03-20	Medtronic, Inc.	Sphere-9 Catheter (AFR-00001)	P240013/S021 FDA
2026-03-06	Medtronic, Inc.	Sphere-9 Catheter (AFR-00001)	P240013/S020 FDA
2026-03-03	Medtronic, Inc.	HexaGen™ RF Generator	P240013/S019 FDA
2026-02-18	Kardium, Inc.	Globe Catheter (601-01000)	P240044/S002 FDA
2026-02-17	Medtronic, Inc.	PulseSelect™ Pulsed Field Ablation (PFA) system	P230017/S009 FDA
2026-02-12	Biosense Webster, Inc.	VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)	P240006/S014 FDA
2026-01-13	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System (FARAPULSE)	P230030/S017 FDA
2026-01-12	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C (truncated in the FDA record)	P230030/S012 FDA
2026-01-09	Kardium, Inc.	Globe® Catheter; Globe® Pulsed Field System	P240044/S004 FDA
2026-01-06	Kardium, Inc.	Globe® Pulsed Field System	P240044/S003 FDA
2026-01-02	Biosense Webster, Inc.	VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump	P240006/S013 FDA
2025-12-19	ABBOTT MEDICAL	Volt™ PFA System	P250022 FDA
2025-08-27	Kardium, Inc.	Globe® Pulsed Field System	P240044 FDA
2024-11-06	Biosense Webster, Inc.	VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)	P240006 FDA
2024-10-24	Medtronic, Inc.	Sphere-9 Catheter and Affera Ablation System	P240013 FDA
2024-01-30	Farapulse, Inc.	FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, (truncated in the FDA record)	P230030 FDA
2023-12-13	Medtronic, Inc.	PulseSelect™ Pulsed Field Ablation (PFA) system	P230017 FDA

510(k) clearances with this code

Every verified record ArrHub holds under the code, newest first.

None in the verified view.

ArrHub

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ArrHub vocabulary

Electrophysiology

QZI is one of the 56 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 20 September 2026.

Raw record

The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.

Show the raw record (JSON)device/classification.json?search=product_code:QZI

{
  "id": "fda_product_code:QZI",
  "vocabulary": "fda_product_code",
  "term": "QZI",
  "definition": "Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation",
  "attrs": {
    "device_class": "3",
    "review_panel": "CV",
    "medical_specialty": "Unknown",
    "regulation_number": ""
  },
  "jurisdiction": "US",
  "authority": "FDA",
  "ep_relevant": true,
  "source_url": "https://api.fda.gov/device/classification.json?search=product_code:QZI",
  "verified_by": "Bruno Deslauriers",
  "verified_at": "2026-09-20T01:22:27.524165+00:00",
  "notes": "Fetched from https://open.fda.gov/apis/device/classification/",
  "created_at": "2026-09-20T01:19:09.890684+00:00",
  "updated_at": "2026-09-20T01:18:55.593+00:00"
}

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