Prodigy Twist™ TWIST6F

by Imperative Care Inc. 2 variants

Prodigy Twist™ TWIST6F 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 27 Jun 2022 (UDI-DI 00850032079013), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850032079013 UDI-DI	Date27 Jun 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK214114	Date6 Apr 2022Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00850032079013
FDA 510(k) database 510(k) number K214114

Across registries

2 registries list this device

FDA 510(k) K214114 decided 6 Apr 2022 Active
FDA GUDID UDI-DI 00850032079013 listed 27 Jun 2022 Listed

Timeline

2 dated events

6 Apr 2022 Cleared FDA 510(k) K214114
27 Jun 2022 Listed FDA GUDID 00850032079013

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Prodigy Twist™
Generic name: Thrombectomy suction catheter
Model / Ref / Catalog: TWIST6F

Primary DI / UDI-DI: 00850032079013
510(k) Number: K214114
FDA product code: QEW
GMDN term: Thrombectomy suction catheter

Device class: Class II
Regulation number: 870.5150
GUDID distribution status: In Commercial Distribution

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)