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Pressure Relief Valve

by Circulatory Technology, Inc.

510(k) K941492

Pressure Relief Valve is a medical device (FDA Class II; FDA product code MNJ, Valve, Pressure Relief, Cardiopulmonary Bypass) made by Circulatory Technology, Inc., cleared under FDA 510(k) K941492 on 26 Oct 1994, active as of 9 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 9 Oct 2026.

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK941492 Date26 Oct 1994ClearedStatusActive

Official records

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  • Withdrawn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
MNJ
Device class
Class II
Regulation
21 CFR Part 870.4400
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

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