Leocor Corflo Pump -- Modification

FDA 510(k) K924110 · Leocor, Inc.

Substantially Equivalent

510(k) numberK924110

Submission

Device name
Leocor Corflo Pump -- Modification
Applicant
Leocor, Inc.
Houston, TX, US
Received
June 3, 1992
Decision date
September 1, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DQI – Withdrawal/Infusion Pump
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1800
Specialty
Cardiovascular

Other 510(k)s with product code DQI

510(k)DeviceApplicantDecision
K960486Ksea Model 383320 20 AngiomatDQI · Traditional Karl Storz Endoscopy10/25/1996SE
K935763SurgipumpDQI · Traditional W.O.M. World of Medicine GmbH04/21/1994SE
K922541Usci Super 9 Ptca Guiding CatheterDQI · Traditional C.R. Bard, Inc.12/08/1992SE
K905189Baxter Angioscopy Pump Tubing Set (Model NL)DQI · Traditional Baxter Healthcare Corp01/30/1991SE
K902444Clearview(Tm) Angioscopic Irrigation PumpDQI · Traditional Intramed Laboratories, Inc.08/30/1990SE
K895688Nobles-Lai Engineering Infusion PumpDQI · Traditional Nobles-Lai Engineering, Inc.02/26/1990SE
K895074Angioscopy PumpDQI · Traditional Baxter Healthcare Corp01/31/1990SE
K871422Olympus Angioscopy PumpDQI · Traditional Olympus Corp.08/12/1987SE

More from Olympus Corp.

510(k)DeviceDecision
K911270Leocor Guiding CatheterDQO · Traditional 01/17/1992SE
K900350Leocor Corflo(Tm) PumpDXK · Traditional 07/17/1990SE

Questions and answers

When was Leocor Corflo Pump -- Modification cleared by the FDA?

Leocor Corflo Pump -- Modification (K924110) received a 510(k) decision of Substantially Equivalent on September 1, 1992, 90 days after the submission was received.

What is the product code of K924110?

The FDA product code is DQI – Withdrawal/Infusion Pump, a Class II (moderate risk) device regulated under 21 CFR 870.1800.