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Inno Hydrowire SW-35-150-A-3-D

by Suzhou Innomed Medical Device 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 Number06971564430111 UDI-DI Date22 Mar 2019ListedStatusListed 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  • Withdrawn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
Inno Hydrowire
Generic Name
Peripheral vascular guidewire, manual
Model / Reference
SW-35-150-A-3-D
Primary DI / UDI-DI
06971564430111
510(k) Number
FDA Product Code
DQX
GMDN Term
Peripheral vascular guidewire, manual
Device Class
Class II
Regulation Number
870.1330
GUDID distribution status
In Commercial Distribution

Related devices

Category: Peripheral vascular guidewire, manual

Cleared under the same submission (K172187)

Other devices from Suzhou Innomed Medical Device Co., Ltd.

See all devices from Suzhou Innomed Medical Device Co., Ltd. →

Properties

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

Other properties (9)

  • 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