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Oscor Medical Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
31
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K964107OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PRApril 1, 1997
K925168MISCELLANEOUS PACING LEADMay 3, 1994
K923621EXTERNAL DEMAND PACEMAKERMay 19, 1993
K912867OSCOR MEDICAL CORP PERMANENT PACING LEADFebruary 4, 1992
K915008PERMANENT PACING PAD, MODIFICATIONJanuary 27, 1992
K915007PERMANENT PACING LEADS, MODIFICATIONJanuary 27, 1992
K913201PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATIONSeptember 23, 1991
K913204MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATIONSeptember 23, 1991
K913203IMPLANT PACING LEAD TINED #3390, MODIFICATIONSeptember 23, 1991
K913393IMPLANT PACING LEAD, RETRACTABLE, MODIFICATIONSeptember 23, 1991
K913202IMPLANT PACING LEAD, TINED #3262, MODIFICATIONSeptember 23, 1991
K913205OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIFSeptember 23, 1991
K913158MODIFIED OSCOR PY PACING LEADS/MODIFICATIONSeptember 23, 1991
K905182OSCOR MEDICAL CORP. PERMANENT PACING PADMay 7, 1991
K905300PERMANENT PACING LEADMay 7, 1991
K884866TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1March 22, 1989
K890277HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORTMarch 10, 1989
K882345PERMANENT PACING LEADS PYBJ SERIESOctober 28, 1988
K882462PERMANENT PACING LEAD MODEL RXBJ SERIESOctober 28, 1988
K882327PACER SENSING ANALYZER (PSA 100)October 6, 1988