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Penumbra System PST3

by Penumbra, Inc.

Ref PST3Model Suction/irrigation tubing, single-use

Penumbra System PST3 is a device classified as Class IIa in the EU and Class II in the US made by Penumbra, Inc., registered in EUDAMED on 26 May 2026 (Basic UDI-DI 081454801PSINDTUB3G), cleared under FDA 510(k) K151623 on 6 Aug 2015 and listed in FDA GUDID since 20 Sep 2022 (UDI-DI 00810169721100), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K151623

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081454801PSINDTUB3G Basic UDI-DI 00810169721100UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810169721100 UDI-DI Date20 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK151623 Date6 Aug 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081454801PSINDTUB3G registered 26 May 2026 Active
  • FDA 510(k) K151623 decided 6 Aug 2015 Active
  • FDA GUDID UDI-DI 00810169721100 listed 20 Sep 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K151623
  2. Listed FDA GUDID 00810169721100
  3. Registered EUDAMED 081454801PSINDTUB3G

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Hi-Flow Aspiration Tubing EUDAMED
Penumbra System GUDID
Generic name
Thrombectomy suction catheter
Device name
Penumbra and INDIGO Aspiration Tubing
Model / reference
PST3, Suction/irrigation tubing, single-use
Primary DI / UDI-DI
00810169721100 EUDAMED
00814548016238 GUDID
Basic UDI-DI
081454801PSINDTUB3G
510(k) Number
FDA product code
NRY
EMDN code
C010402020702 Mechanical peripheral thrombectomy and thromboaspiration systems
GMDN term
Thrombectomy suction catheter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1250
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00810169721100
GUDID
00814548016238
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00810169721100; FDA GUDID lists 00814548016238), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Thrombectomy suction catheter

Cleared under the same submission (K151623)

Similar devices in this category

Other devices filed under PERIPHERAL THROMBECTOMY AND THROMBOASPIRATION SYSTEMS.

Other devices from Penumbra, Inc.

See all devices from Penumbra, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (20, all answered No)