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510(k) K920077

NIKKISO NK PUMP by International Medical Products, Inc. — Product Code DWD

K920077 is an FDA 510(k) premarket notification submitted by International Medical Products, Inc. for the device "NIKKISO NK PUMP". The FDA issued a decision of Substantially Equivalent on September 29, 1993. The device falls under product code DWD (Suction Control, Intracardiac, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4430. International Medical Products, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1993
Date Received
January 8, 1992
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 Medical Products, Inc.

  • K981069 — ULTRA-COVER PU-TRANSDUCER COVER (September 23, 1998)
  • K981003 — ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES (June 16, 1998)
  • K973253 — ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE (October 30, 1997)
  • K971053 — ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE D (June 16, 1997)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)
  • K900755 — DIGITAL CUFF PV GAUGE (April 26, 1990)
  • K864984 — ROBINJECT (June 29, 1987)
  • K863609 — SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 (February 25, 1987)
  • K861539 — NIKKISO INFUSION PUMP MODEL PFA-02 (July 31, 1986)

Other clearances for product code DWD

  • K992657 — IBC VRV, MODEL 1350 (February 18, 2000)
  • 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