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Indigo System LITNGFHT80BER-D

by Penumbra, Inc.

Indigo System LITNGFHT80BER-D is a Class II device made by Penumbra, Inc., cleared under FDA 510(k) K241399 on 10 Jun 2024 and listed in FDA GUDID since 18 Jul 2024 (UDI-DI 00815948029859), 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) K241399

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 Number00815948029859 UDI-DI Date18 Jul 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK241399 Date10 Jun 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241399 decided 10 Jun 2024 Active
  • FDA GUDID UDI-DI 00815948029859 listed 18 Jul 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241399
  2. Listed FDA GUDID 00815948029859

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Indigo System
Generic name
Thrombectomy suction catheter
Model / reference
LITNGFHT80BER-D
Primary DI / UDI-DI
00815948029859
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

Related devices

Category: Thrombectomy suction catheterThrombectomy aspiration management software

Cleared under the same submission (K241399)

and 2 more cleared under K241399

Similar devices

Other devices filed under FDA product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Other devices from Penumbra, Inc.

See all devices from Penumbra, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)