Cool Path™ A700241

by Irvine Biomedical, Inc.

Cool Path™ A700241 is a Class III device made by Irvine Biomedical, Inc., approved under FDA PMA P110016 on 25 Jan 2012 and listed in FDA GUDID since 29 Sep 2014 (UDI-DI 05415067002419), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05415067002419 UDI-DI	Date29 Sep 2014Listed	StatusListed GUDID: in commercial distribution
United States	FDA PMAAPPR from GUDID Approved	NumberP110016	Date25 Jan 2012Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05415067002419
FDA PMA database PMA number P110016

Across registries

2 registries list this device

FDA PMA P110016 decided 25 Jan 2012 Active
FDA GUDID UDI-DI 05415067002419 listed 29 Sep 2014 Listed

Timeline

2 dated events

25 Jan 2012 Approved FDA PMA P110016
29 Sep 2014 Listed FDA GUDID 05415067002419

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name: Cool Path™
Generic name: Cardiac radio-frequency ablation system catheter
Model / Ref / Catalog: A700241

Primary DI / UDI-DI: 05415067002419
PMA number: P110016
FDA product code: OAD
GMDN term: Cardiac radio-frequency ablation system catheter

Device class: Class III
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

Size: Catheter Gauge — 8 French

Similar devices in this category

Other devices filed under Cardiac radio-frequency ablation system catheter.

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)