Cleared Traditional

K900350 - LEOCOR CORFLO(TM) PUMP

K900350 is an FDA 510(k) clearance for LEOCOR CORFLO(TM) PUMP, manufactured by Leocor, Inc.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K900350 · Leocor, Inc. · Cardiovascular device
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Jul 1990
Decision
174d
Days
Class 2
Risk

K900350 is an FDA 510(k) clearance for the LEOCOR CORFLO(TM) PUMP. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Leocor, Inc. (Webster, US). The FDA issued a Cleared decision on July 17, 1990 after a review of 174 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Leocor, Inc. devices

FDA 510(k) Submission Details - K900350

510(k) Number K900350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1990
Decision Date July 17, 1990
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXK Device Classification - Class 2, Special Controls

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXK Echocardiograph

All 47
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K900350.
MODEL MD-5 DOPPLER
K901592 · D. E. Hokanson, Inc. · Oct 1990
ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND
K901657 · Hitachi Medical Corp. of America · Sep 1990
ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND
K901658 · Hitachi Medical Corp. of America · Sep 1990
CVIS INSIGHT IMAGING CATHETER
K901562 · Cardiovascular Imaging Systems, Inc. · Jul 1990
DOPPLER OPTION FOR PLATINUM
K900002 · Philips Medical Systems North America, Inc. · Apr 1990
EUB-165
K895326 · Hitachi Medical Corp. of America · Mar 1990