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510(k) K992657

IBC VRV, MODEL 1350 by International Biophysics Corp. — Product Code DWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2000
Date Received
August 9, 1999
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

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  • K992785 — IBC FLOGUARD, MODEL 6050 (January 14, 2000)
  • K992964 — IBC VENT VALVE, MODEL 1400 (November 19, 1999)
  • K983272 — IBC FLOPUMP, MODEL 6000 (March 24, 1999)
  • K963703 — ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) (April 8, 1998)
  • K963756 — IBC CARDIAC SUCTION WARD (November 14, 1997)
  • K963698 — CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 (March 20, 1997)
  • K955379 — IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) (May 14, 1996)
  • K955380 — IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) (May 14, 1996)

Other clearances for product code DWD

  • K920077 — NIKKISO NK PUMP (September 29, 1993)
  • K915482 — B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT (January 7, 1992)
  • K915480 — B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. (January 7, 1992)
  • K915481 — B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT (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)
  • K861428 — SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 (June 26, 1986)