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510(k) K924110

LEOCOR CORFLO PUMP -- MODIFICATION by Leocor, Inc. — Product Code DQI

K924110 is an FDA 510(k) premarket notification submitted by Leocor, Inc. for the device "LEOCOR CORFLO PUMP -- MODIFICATION". The FDA issued a decision of Substantially Equivalent on September 1, 1992. The device falls under product code DQI (Withdrawal/Infusion Pump), a Class II device regulated under 21 CFR 870.1800. Leocor, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1992
Date Received
June 3, 1992
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 Leocor, Inc.

  • K911270 — LEOCOR GUIDING CATHETER (January 17, 1992)
  • K900350 — LEOCOR CORFLO(TM) PUMP (July 17, 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)
  • 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)
  • K895074 — ANGIOSCOPY PUMP (January 31, 1990)
  • K871422 — OLYMPUS ANGIOSCOPY PUMP (August 12, 1987)

FDA data resources