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Prodigy™ Catheter PRODIGY6F

by Imperative Care Inc. 2 variants

Prodigy™ Catheter PRODIGY6F is a Class II device made by Imperative Care Inc., cleared under FDA 510(k) K214114 on 6 Apr 2022 and listed in FDA GUDID since 10 Aug 2022 (UDI-DI 00850032079051), active as of 22 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 22 Oct 2026

Documents

510(k) K214114

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850032079051 UDI-DI Date10 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK214114 Date6 Apr 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K214114 decided 6 Apr 2022 Active
  • FDA GUDID UDI-DI 00850032079051 listed 10 Aug 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K214114
  2. Listed FDA GUDID 00850032079051

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Prodigy™ Catheter
Generic name
Thrombectomy suction catheter
Model / Ref / Catalog
PRODIGY6F
Primary DI / UDI-DI
00850032079051
510(k) Number
FDA product code
QEW
GMDN term
Thrombectomy suction catheter
Device class
Class II
Regulation number
870.5150
GUDID distribution status
In Commercial Distribution
Size
Introducer Sheath Compatibility — 6 French
Catheter Length — 137 Centimeter

Related devices

Category: Thrombectomy suction catheter

Cleared under the same submission (K214114)

and 4 more cleared under K214114

Similar devices in this category

Other devices filed under Thrombectomy suction catheter.

Other devices from Imperative Care Inc.

See all devices from Imperative Care Inc. →

Properties

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