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Thd Revolution (Us)

by Thd SpA

Thd Revolution (Us) (800139) is a Class II device made by Thd SpA, cleared under FDA 510(k) K141657 on 24 Feb 2015 and listed in FDA GUDID since 14 Apr 2017 (UDI-DI 18033737710842), 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) K141657

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 Number18033737710842 UDI-DI Date14 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK141657 Date24 Feb 2015IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141657 decided 24 Feb 2015 Active
  • FDA GUDID UDI-DI 18033737710842 listed 14 Apr 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141657
  2. Listed FDA GUDID 18033737710842

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Thd Revolution
Generic name
Invasive vascular ultrasound system
Model / Ref / Catalog
THD REVOLUTION (US), 800139
Primary DI / UDI-DI
18033737710842
510(k) Number
FDA product code
JAF
GMDN term
Invasive vascular ultrasound system
Device class
Class II
Regulation number
892.1540
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code JAF (Monitor, Ultrasonic, Nonfetal).

Other devices from Thd SpA

See all devices from Thd SpA →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)