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Radifocus XX*RF02AH

by Terumo Medical Products (Hangzhou) Co., Ltd.

Radifocus XX*RF02AH (TD01) is a Class II device made by Terumo Medical Products (Hangzhou) Co., Ltd., cleared under FDA 510(k) K220934 on 29 Jun 2022 and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 36927675513480), active as of 23 Oct 2026.

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 23 Oct 2026

Documents

510(k) K220934

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number36927675513480 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220934 Date29 Jun 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220934 decided 29 Jun 2022 Active
  • FDA GUDID UDI-DI 36927675513480 listed 8 Dec 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220934
  2. Listed FDA GUDID 36927675513480

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Radifocus
Generic name
Torque manipulation device
Model / Ref / Catalog
XX*RF02AH, TD01
Description
Torque Device
Primary DI / UDI-DI
36927675513480
510(k) Number
FDA product code
MOF, PTL
GMDN term
Torque manipulation device
Device class
Class II
Regulation number
870.1330
GUDID distribution status
In Commercial Distribution

Related devices

Category: Torque manipulation device

Similar devices

Other devices filed under FDA product code MOF (Guide, Wire, Catheter, Neurovasculature).

Other devices from Terumo Medical Products (Hangzhou) Co., Ltd.

See all devices from Terumo Medical Products (Hangzhou) Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)