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AngioVac Circuit

by Angiodynamics

510(k) K142607

AngioVac Circuit is a Class II device made by Angiodynamics, cleared under FDA 510(k) K142607 on 11 Dec 2014, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142607 Date11 Dec 2014ClearedStatusActive

Official records

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

2 dated events

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DWE
Device class
Class II
Regulation
21 CFR Part 870.4390
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K142607

6 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K142607
UDI-DISize and differences
AngioDynamics 25187
NAVILYST MEDICAL, INC.
25187H965251870 —No longer on the market
AngioVac 25188
ANGIODYNAMICS, INC.
25188H965251880 —No longer on the market
AngioVac 25199
ANGIODYNAMICS, INC.
25199H965251990 —No longer on the market
AngioVac H965251880
ANGIODYNAMICS, INC.
25188 / H96525188015051684019859 —On the market
AngioVac H965251990
ANGIODYNAMICS, INC.
25199 / H96525199015051684019866 —On the market
AngioVac H965252810
NAVILYST MEDICAL, INC.
H965252810H965252810 —On the market

Similar devices

Other devices filed under FDA product code DWE (Tubing, Pump, Cardiopulmonary Bypass).

Other devices from Angiodynamics, Inc