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

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	OAD	product_code
Device name	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	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 OAD, 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
2026-09-03	Irvine Biomedical,Inc.(Ibi)	Therapy™ Dual-8™ Ablation Catheter	P040042/S060 FDA
2026-09-02	Biosense Webster, Inc.	THERMOCOOL SMARTTOUCH® SF Catheter	P030031/S142 FDA
2026-08-07	ABBOTT MEDICAL	Ampere Generator	P110016/S095 FDA
2026-08-07	Irvine Biomedical, Inc.	Ampere Generator	P060019/S059 FDA
2026-08-07	Irvine Biomedical,Inc.(Ibi)	Ampere Generator	P040042/S059 FDA
2026-07-01	Biosense Webster, Inc.	Dual Energy THERMOCOOL SMARTTOUCH SF™ System	P030031/S141 FDA
2026-06-30	Biosense Webster, Inc.	VISITAG SURPOINT™ External Processing Unit (“EPU”); CARTO 3 System	P030031/S143 FDA
2026-06-10	Biosense Webster, Inc.	THERMOCOOL SMARTTOUCH SF (Uni-Directional and Bi-Directional)/DUAL ENERGYTHERMOCOOL SMARTTOUCH SF CATHETERS	P030031/S144 FDA
2026-06-05	ABBOTT MEDICAL	FlexAbility™ Ablation Catheter; FlexAbilityTM Ablation Catheter, Sensor EnabledTM	P110016/S094 FDA
2026-04-09	ABBOTT MEDICAL	FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE)	P110016/S093 FDA
2026-01-15	ABBOTT MEDICAL	FlexAbility™ and FlexAbility™ Sensor Enabled™	P110016/S092 FDA
2026-01-15	Irvine Biomedical,Inc.(Ibi)	Safire™ TX Bi-directional and Therapy™ Dual-8™	P040042/S058 FDA
2026-01-08	ABBOTT MEDICAL	FlexAbility™ Ablation Catheter (Flex) and FlexAbility™ Ablation Catheter, Sensor Enabled™ (Flex SE)	P110016/S091 FDA
2012-01-25	ABBOTT MEDICAL	THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR	P110016 FDA
2007-03-16	Irvine Biomedical, Inc.	IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF	P060019 FDA
2005-11-18	Irvine Biomedical,Inc.(Ibi)	THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER	P040042 FDA
2004-11-05	Biosense Webster, Inc.	BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS	P030031 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

OAD 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:OAD

{
  "id": "fda_product_code:OAD",
  "vocabulary": "fda_product_code",
  "term": "OAD",
  "definition": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter",
  "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:OAD",
  "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": "2026-09-20T01:19:09.438213+00:00",
  "updated_at": "2026-09-20T01:18:55.131+00:00"
}

The readable page is rendered from the record held in ArrHub’s verified view; the agency record at api.fda.gov governs where they differ.

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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