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510(k) K921500

CENTRI-SAFE(TM) VALVE by Cardio Systems, Inc. — Product Code MJJ

K921500 is an FDA 510(k) premarket notification submitted by Cardio Systems, Inc. for the device "CENTRI-SAFE(TM) VALVE". The FDA issued a decision of Substantially Equivalent on September 15, 1992. The device falls under product code MJJ (Cpb Check Valve, Retrograde Flow, In-Line), a Class II device regulated under 21 CFR 870.4400. Cardio Systems, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1992
Date Received
March 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cpb Check Valve, Retrograde Flow, In-Line
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

Other clearances by Cardio Systems, Inc.

  • K131092 — STEALTH 360 ORBITAL PAD SYSTEM (June 24, 2013)
  • K081944 — MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM (August 14, 2008)
  • K972022 — ZAK-2000 (January 22, 1998)
  • K934689 — LOW AIR LOSS MATTRESS, MODIFICATION (February 2, 1994)
  • K882177 — ADD-ON TO CRITICAL PATIENT CARE BED (December 1, 1988)
  • K852736 — BAYLOR RAPID AUTOTRANSFUSION SYSTEM (September 18, 1985)
  • K792152 — CARDIOPLEGIA SOLUTION ADMIN. SET (November 13, 1979)
  • K792151 — OXYGENATOR GAS LINE FILTER (November 13, 1979)

Other clearances for product code MJJ

  • K182442 — MiniGuard Arterial Safety Valve (November 6, 2018)
  • K142500 — One Way Soft Valve (January 29, 2015)
  • K001245 — 3T L. V. CONTROL VALVE (August 15, 2001)
  • K992785 — IBC FLOGUARD, MODEL 6050 (January 14, 2000)
  • K982406 — COBE VACUUM RELIEF CHECK VALVE (October 7, 1998)
  • K960937 — SUCTION SAFETY DEVICE (June 5, 1996)
  • K922781 — FLOW CONROL VALVE (March 8, 1993)
  • K922356 — FLOW CONTROL VALVE, CAT. NO. ACV-38 (February 12, 1993)

FDA data resources