Home / 510(k) Clearances / K941492

510(k) K941492

PRESSURE RELIEF VALVE by Circulatory Technology, Inc. — Product Code MNJ

K941492 is an FDA 510(k) premarket notification submitted by Circulatory Technology, Inc. for the device "PRESSURE RELIEF VALVE". The FDA issued a decision of Substantially Equivalent on October 26, 1994. The device falls under product code MNJ (Valve, Pressure Relief, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Circulatory Technology, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1994
Date Received
March 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Pressure Relief, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

Other clearances by Circulatory Technology, Inc.

  • K140321 — INITARY BETTER BLADDER-PEDIATRIC (April 17, 2014)
  • K012942 — THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, C (November 5, 2001)
  • K001822 — THE V-BAG (July 7, 2000)
  • K981284 — BETTER-BLADDER (BB) (August 12, 1998)
  • K964205 — BETTER-TUBING (April 8, 1998)
  • K964337 — BETTER-BLADDER (BB) (May 23, 1997)
  • K961594 — BETTER-VENTER (September 5, 1996)
  • K942933 — PRESSURE INFUSION CUFF (August 25, 1994)

Other clearances for product code MNJ

  • K992964 — IBC VENT VALVE, MODEL 1400 (November 19, 1999)

FDA data resources