Atlas FDA

LEOCOR CORFLO(TM) PUMP

FDA 510(k) clearance K900350 · decided 1990-07-17

Clearance details

K-number
K900350
Device name
LEOCOR CORFLO(TM) PUMP
Applicant
Leocor, Inc.
Decision
Substantially Equivalent
Date received
1990-01-24
Decision date
1990-07-17
Days to decision
174 days
Clearance type
Traditional
Product code
DXK
Device class
2
Regulation number
870.2330
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Webster, TX, US
Third-party review
No
Expedited review
No

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MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST (K904832)Hewlett-Packard Co.1991-04-22
VISTA VIEWING STATION (K904975)Prism Imaging, Inc.1991-02-25
SOFTWARE PROGRAM USED W/PRISM PRODUCTS (K904978)Prism Imaging, Inc.1991-02-25
CINE'VIEW - STRESS ECHO & IMAGE REVIEW (K904976)Prism Imaging, Inc.1991-02-25
CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (K904977)Prism Imaging, Inc.1991-02-25
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
LEOCOR SABLE(TM) PTCA CATHETER (P890001/S018)Leocor, Inc.1997-06-11
LEOCOR PICO-ST (P890001/S019)Leocor, Inc.1997-06-09
LEOCOR SABLE(TM) PTCA CATHETER (P890001/S020)Leocor, Inc.1997-01-16
LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT (P890001/S016)Leocor, Inc.1996-09-17
LEOCOR PERCUTANEOUS ANGIOPLASTY CATHETER (PTCA), MODEL 5S, LEOCOR CORFLO MODEL 7.5PT COATED PTCA, AND CORFLO HEMO PUMP (P890001/S011)Leocor, Inc.1996-06-13
LEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED) (P890001/S014)Leocor, Inc.1996-06-13
LEOCOR PICO RUNNER(TM) PTCA CATHETER (P890001/S015)Leocor, Inc.1996-06-07
LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT (P890001/S012)Leocor, Inc.1995-04-27