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510(k) K902444

CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP by Intramed Laboratories, Inc. — Product Code DQI

K902444 is an FDA 510(k) premarket notification submitted by Intramed Laboratories, Inc. for the device "CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP". The FDA issued a decision of Substantially Equivalent on August 30, 1990. The device falls under product code DQI (Withdrawal/Infusion Pump), a Class II device regulated under 21 CFR 870.1800. Intramed Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1990
Date Received
June 1, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Withdrawal/Infusion Pump
Device Class
Class II
Regulation Number
870.1800
Review Panel
HO
Submission Type

Other clearances by Intramed Laboratories, Inc.

  • K953258 — TITANIUM HEMOSTATIC CLIP (January 5, 1996)
  • K942457 — GRAFT THROMBECTOMY INSTRUMENTS (February 7, 1995)
  • K931792 — ARTHROSCOPE (June 13, 1994)
  • K925283 — VALVULOTOME (February 10, 1994)
  • K934696 — ANGIOSCOPE (January 18, 1994)
  • K922114 — ENDOSCOPIC RETRIEVAL BASKET (August 3, 1992)
  • K914385 — OPTICAL VALVULOTOME (March 2, 1992)
  • K904465 — FLEXIBLE ARTHROSCOPE (December 20, 1990)
  • K903528 — LAPAROSCOPE (September 4, 1990)
  • K901010 — FLEXIBLE CHOLEDOCHOSCOPE (May 22, 1990)

Other clearances for product code DQI

  • K960486 — KSEA MODEL 383320 20 ANGIOMAT (October 25, 1996)
  • K935763 — SURGIPUMP (April 21, 1994)
  • K922541 — USCI SUPER 9 PTCA GUIDING CATHETER (December 8, 1992)
  • K924110 — LEOCOR CORFLO PUMP -- MODIFICATION (September 1, 1992)
  • K905189 — BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) (January 30, 1991)
  • K895688 — NOBLES-LAI ENGINEERING INFUSION PUMP (February 26, 1990)
  • K895074 — ANGIOSCOPY PUMP (January 31, 1990)
  • K871422 — OLYMPUS ANGIOSCOPY PUMP (August 12, 1987)

FDA data resources