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510(k) K895074

ANGIOSCOPY PUMP by Baxter Healthcare Corp — Product Code DQI

K895074 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ANGIOSCOPY PUMP". The FDA issued a decision of Substantially Equivalent on January 31, 1990. The device falls under product code DQI (Withdrawal/Infusion Pump), a Class II device regulated under 21 CFR 870.1800. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1990
Date Received
August 14, 1989
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 Baxter Healthcare Corp

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  • K192705 — MiniCap Extended Life PD Transfer Sets (October 25, 2019)
  • K190910 — PrisMax System Version 2 (July 25, 2019)
  • K163530 — PrisMax Control Unit (May 3, 2017)
  • K152675 — EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER A (October 29, 2015)
  • K130531 — ULTRAFUSE (April 8, 2014)
  • K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION (October 8, 2013)
  • K130245 — LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENS (March 1, 2013)
  • K123874 — INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS (January 10, 2013)
  • K123868 — INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, (January 8, 2013)

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)
  • K902444 — CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP (August 30, 1990)
  • K895688 — NOBLES-LAI ENGINEERING INFUSION PUMP (February 26, 1990)
  • K871422 — OLYMPUS ANGIOSCOPY PUMP (August 12, 1987)

FDA data resources