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510(k) K922781

FLOW CONROL VALVE by American Omni Medical, Inc. — Product Code MJJ

K922781 is an FDA 510(k) premarket notification submitted by American Omni Medical, Inc. for the device "FLOW CONROL VALVE". The FDA issued a decision of Substantially Equivalent on March 8, 1993. The device falls under product code MJJ (Cpb Check Valve, Retrograde Flow, In-Line), a Class II device regulated under 21 CFR 870.4400. American Omni Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1993
Date Received
June 9, 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 American Omni Medical, Inc.

  • K922356 — FLOW CONTROL VALVE, CAT. NO. ACV-38 (February 12, 1993)
  • K900672 — PREBYPASS FILTER, CAT. NO. FPB-5 (April 3, 1990)
  • K884893 — CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (January 30, 1989)
  • K884640 — CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (January 24, 1989)
  • K873316 — BUBBLE TRAP-FILTER CAT. NO B180F37 (July 14, 1988)
  • K875080 — AIR VENT LINE CAT. NO. AVL-36 (February 29, 1988)
  • K873802 — PRESSURE BARRIER KIT CAT. NO. PBK-3 (November 6, 1987)
  • K873610 — PEDIATRIC BUBBLE TRAP CAT. NO. B-100 (November 5, 1987)
  • K873488 — SILENT GUARD CAT. NO. SG-10 (October 7, 1987)
  • K871632 — NASOGASTRIC VOICETUBE (September 16, 1987)

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)
  • K922356 — FLOW CONTROL VALVE, CAT. NO. ACV-38 (February 12, 1993)
  • K921500 — CENTRI-SAFE(TM) VALVE (September 15, 1992)

FDA data resources