Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

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	OAE	product_code
Device name	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	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 OAE, 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
2026-08-17	Biosense Webster, Inc.	TX eco Cable	P210027/S017 FDA
2026-08-07	ABBOTT MEDICAL	TactiSys Quartz Equipment; Ampere Generator	P220013/S033 FDA
2026-08-07	St Jude Medical	TactiSys Quartz Equipment; Ampere Generator	P130026/S102 FDA
2026-08-06	Medtronic Cryocath, LP	Stop AF First	P100010/S152 FDA
2026-07-23	ABBOTT MEDICAL	TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C (truncated in the FDA record)	P220013/S030 FDA
2026-06-05	ABBOTT MEDICAL	TactiFlex™ Ablation Catheter, Sensor Enabled™	P220013/S031 FDA
2026-06-05	St Jude Medical	TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™	P130026/S100 FDA
2026-05-29	Boston Scientific Corporation	POLARx and POLARx Cryoablation Balloon Catheters; POLARSHEATH Steerable Sheaths; SMARTFREEZE Cryoablation System Console (truncated in the FDA record)	P220032/S012 FDA
2026-05-29	ABBOTT MEDICAL	TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex™ SE)	P220013/S032 FDA
2026-05-29	St Jude Medical	TactiCath™ Ablation Catheter, Sensor Enabled™ (TactiCath™ SE)	P130026/S101 FDA
2026-05-28	ABBOTT MEDICAL	TactiFlex™ Sensor Enabled™ Ablation Catheter	P220013/S022 FDA
2026-05-15	ABBOTT MEDICAL	TactiFlex™ Ablation Catheter, Sensor Enabled™ (A-TFSE-D; A-TFSE-F; A-TFSE-J; A-TFSE-DD; A-TFSE-DF; A-TFSE-FF; A-TFSE-FJ; (truncated in the FDA record)	P220013/S029 FDA
2026-05-15	St Jude Medical	TactiCath™ CF Ablation Catheter, Sensor Enabled™ (A-TCSE-D; A-TCSE-F; A-TCSE-J; A-TCSE-DD; A-TCSE-DF; A-TCSE-FF; A-TCSE- (truncated in the FDA record)	P130026/S099 FDA
2026-04-23	Medtronic Cryocath, LP	Freezor MAX 209F3,209F5	P100010/S153 FDA
2026-04-17	Biosense Webster, Inc.	QDOT MICRO™ System	P210027/S016 FDA
2026-02-03	ABBOTT MEDICAL	TactiFlex Ablation Catheter SE (A-TFSE-D, A-TFSE-F, A-TFSE-J, A-TFSE-DD, A-TFSE-DF, A-TFSE-FF, A-TFSE-FJ, A-TFSE-JJ, A-T (truncated in the FDA record)	P220013/S027 FDA
2026-01-15	ABBOTT MEDICAL	TactiFlex™ Sensor Enabled™	P220013/S026 FDA
2026-01-15	St Jude Medical	TactiCath™ Sensor Enabled™	P130026/S098 FDA
2026-01-08	ABBOTT MEDICAL	TactiFlex™ Ablation Catheter, Sensor Enabled™ (TactiFlex SE)	P220013/S025 FDA
2026-01-08	St Jude Medical	TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)	P130026/S097 FDA
2023-08-08	Boston Scientific Corporation	POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories	P220032 FDA
2023-05-18	ABBOTT MEDICAL	TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C (truncated in the FDA record)	P220013 FDA
2022-11-23	Biosense Webster, Inc.	QDOT MICRO™ System	P210027 FDA
2014-10-24	St Jude Medical	TACTICATH QUARTZ SET	P130026 FDA
2010-12-17	Medtronic Cryocath, LP	ARCTIC FRONT CRYOCATHETER SYSTEM	P100010 FDA

510(k) clearances with this code

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

None in the verified view.

ArrHub

What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.

ArrHub vocabulary

Electrophysiology

OAE 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:OAE

{
  "id": "fda_product_code:OAE",
  "vocabulary": "fda_product_code",
  "term": "OAE",
  "definition": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation",
  "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:OAE",
  "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": "2026-09-20T01:19:08.9525+00:00",
  "updated_at": "2026-09-20T01:18:54.512+00:00"
}

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Links open the agency’s own records. Unlabelled links open web pages. Links marked (JSON) open an agency’s data record, which a browser shows as plain text.

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