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DCwire™ FG62001023

by Shanghai Achieva Medical 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 Number06971428595864 UDI-DI Date3 Jul 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  • Withdrawn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
DCwire™
Generic Name
Cardiac/peripheral vascular guidewire, single-use
Model / Reference
FG62001023
Primary DI / UDI-DI
06971428595864
510(k) Number
FDA Product Code
MOF, DQX
GMDN Term
Cardiac/peripheral vascular guidewire, single-use
Device Class
Class II
Regulation Number
870.1330
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K252122)

Other devices from Shanghai Achieva Medical Suzhou Co., Ltd.

See all devices from Shanghai Achieva Medical Suzhou Co., Ltd. →

Properties

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

Other properties (8)

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