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510(k) K182442

MiniGuard Arterial Safety Valve by Quest Medical, Inc. — Product Code MJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2018
Date Received
September 7, 2018
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

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  • K173716 — MPS2 Myocardial Protection System Console (October 1, 2018)
  • K162804 — Q2 Low Pressure Power Injection Extension Set (March 8, 2017)
  • K162304 — Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV A (December 6, 2016)
  • K151079 — Q2 Intravenous Adminstration Sets and Extension Sets (September 30, 2015)

Other clearances for product code MJJ

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