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Inno-Hydrowire

by Suzhou Innomed Medical Device Co., Ltd.

510(k) K172187

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06971564430395 UDI-DI Date15 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK172187 Date11 Apr 2018ClearedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

510(k) · GUDID

Generic Name
Peripheral vascular guidewire, manual
Model / Reference
SW-35-180-A-3-H
Primary DI / UDI-DI
06971564430395
510(k) Number
FDA Product Code
DQX
GMDN Term
Peripheral vascular guidewire, manual
Device Class
Class II
Regulation
21 CFR Part 870.1330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

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