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510(k) K992657

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

K992657 is an FDA 510(k) premarket notification submitted by International Biophysics Corp. for the device "IBC VRV, MODEL 1350". The FDA issued a decision of Substantially Equivalent on February 18, 2000. The device falls under product code DWD (Suction Control, Intracardiac, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4430. International Biophysics Corp. has at least 10 other 510(k) clearances on record.

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

Other clearances by International Biophysics Corp.

  • K072688 — LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 (January 11, 2008)
  • K030181 — INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM (April 17, 2003)
  • 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)
  • K915481 — B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT (January 7, 1992)
  • 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)
  • 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)

FDA data resources