Daig Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
63
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K000004ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509November 29, 2000
K994334ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXXMay 15, 2000
K982299SPYGLASS 5 FR ANGIOGRAPHIC CATHETEROctober 19, 1998
K982187FAST-CATH INTRA-CARDIAC INTRODUCERSeptember 16, 1998
K973840FAST-CATH (TM) INTRA-CARDIAC INTRODUCERMay 21, 1998
K964518FAST-CATH TRANSSEPTAL CATHETER INTRODUCERMay 14, 1997
K965249SPYGLASS ANGIOGRAPHIC CATHETERFebruary 21, 1997
K962805SPYGLASS ANGIOGRAPHIC CATHETEROctober 15, 1996
K954317DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKSNovember 28, 1995
K944284CONTROLMarch 3, 1995
K942379DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERDecember 27, 1994
K934285CATHETER INTRODUCER MODIFICATIONNovember 24, 1993
K913940RESPONSE(TM) STEERABLE CATHETERJanuary 26, 1993
K920779FAST-CATH HEMOSTASIS INTRODUCERJune 3, 1992
K920327DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCERApril 16, 1992
K914278DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMENMarch 4, 1992
K914185PACEL(TM) FLOW DIRECTED PACING CATHETERJanuary 27, 1992
K914090DAIG FAST CATH(TM) INTRODUCER, MODIFICATIONOctober 28, 1991
K910861PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCKMay 7, 1991
K892528FIVE-YEAR STERILE PACKAGING SHELF LIFEJanuary 18, 1990