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510(k) K982406

COBE VACUUM RELIEF CHECK VALVE by Cobe Cardiovascular, Inc. — Product Code MJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1998
Date Received
July 10, 1998
Clearance Type
Abbreviated
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

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  • K040184 — DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER (February 26, 2004)
  • K033641 — SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 (December 11, 2003)
  • K030462 — COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 (March 6, 2003)
  • K021830 — SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM (July 2, 2002)
  • K011835 — COBE REVOLUTION (February 12, 2002)
  • K013480 — COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR (November 16, 2001)
  • K012763 — SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM (November 15, 2001)
  • K001509 — STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE (October 26, 2001)

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)
  • 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)
  • K921500 — CENTRI-SAFE(TM) VALVE (September 15, 1992)