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510(k) K861428

SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 by American Omni Medical, Inc. — Product Code DWD

K861428 is an FDA 510(k) premarket notification submitted by American Omni Medical, Inc. for the device "SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100". The FDA issued a decision of Substantially Equivalent on June 26, 1986. The device falls under product code DWD (Suction Control, Intracardiac, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4430. American Omni Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1986
Date Received
April 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suction Control, Intracardiac, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4430
Review Panel
CV
Submission Type

Other clearances by American Omni Medical, Inc.

  • K922781 — FLOW CONROL VALVE (March 8, 1993)
  • 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)

Other clearances for product code DWD

  • K992657 — IBC VRV, MODEL 1350 (February 18, 2000)
  • K920077 — NIKKISO NK PUMP (September 29, 1993)
  • K915482 — B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT (January 7, 1992)
  • K915481 — B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT (January 7, 1992)
  • K915480 — B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. (January 7, 1992)
  • K905311 — DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. (January 15, 1991)
  • K895427 — MEDISEAL SUCTION CANISTER (January 19, 1990)
  • K864503 — MODIFIED RLV-2100 B (January 6, 1987)
  • K863593 — SARNS SAFETY LOOP (November 18, 1986)
  • K862540 — LEFT VENTRICULAR VENT VALVE MODEL NO. GLV (August 29, 1986)

FDA data resources