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Parafleet SC 014 PTA Balloon Dilatation Catheter rev 02

by BrosMed Medical Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06942265505347 UDI-DI Date10 May 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Parafleet SC 014 PTA Balloon Dilatation Catheter
Generic Name
Peripheral angioplasty balloon catheter, basic
Model / Ref / Catalog
rev 02, F14-050120-150
Primary DI / UDI-DI
06942265505347
FDA Product Code
LIT
GMDN Term
Peripheral angioplasty balloon catheter, basic
Device Class
Class II
Regulation Number
870.1250
GUDID distribution status
In Commercial Distribution

Related devices

Category: Peripheral angioplasty balloon catheter, basic

Cleared under the same submission (K243704)

Other devices from BrosMed Medical Co., Ltd.

See all devices from BrosMed Medical Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No