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AngioVac H965252810

by Navilyst Medical, Inc.

AngioVac H965252810 is a Class II device made by Navilyst Medical, Inc., cleared under FDA 510(k) K142607 on 11 Dec 2014 and listed in FDA GUDID since 11 May 2020 (UDI-DI H965252810), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K142607

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 NumberH965252810 UDI-DI Date11 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142607 Date11 Dec 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142607 decided 11 Dec 2014 Active
  • FDA GUDID UDI-DI H965252810 listed 11 May 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-1702-2016 FDA Class II initiated 21 Mar 2016

    Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs.

Timeline

3 dated events

  1. Cleared FDA 510(k) K142607
  2. Recall initiated FDA recalls Z-1702-2016
  3. Listed FDA GUDID H965252810

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AngioVac
Generic name
Cardiopulmonary bypass system blood tubing set
Model / reference
H965252810
Primary DI / UDI-DI
H965252810
510(k) Number
FDA product code
DWE
GMDN term
Cardiopulmonary bypass system blood tubing set
Device class
Class II
Regulation number
870.4390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiopulmonary bypass system blood tubing set

Cleared under the same submission (K142607)

Similar devices

Other devices filed under FDA product code DWE (TUBING, PUMP, CARDIOPULMONARY BYPASS).

Other devices from Navilyst Medical, Inc.

See all devices from Navilyst Medical, Inc. →

Properties

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