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Falspeed PTA Balloon Dilatation Catheter KPTA70100L

by Kossel Medtech (Suzhou) 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 Number06954615603696 UDI-DI Date28 Apr 2026ListedStatusListed 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  • Withdrawn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
Falspeed PTA Balloon Dilatation Catheter
Generic name
Peripheral angioplasty balloon catheter, basic
Model / reference
KPTA70100L
Primary DI / UDI-DI
06954615603696
510(k) Number
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

Cleared under the same submission (K221245)

Show all (12)

Other devices from Kossel Medtech (Suzhou) Co., Ltd.

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Properties

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

Other properties (10)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No