Cardio Systems, Inc.

FDA Regulatory Profile

Cardio Systems, Inc. appears in FDA public data with 0 recalls, 9 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 24, 2013.

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K131092STEALTH 360 ORBITAL PAD SYSTEMJune 24, 2013
K081944MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEMAugust 14, 2008
K972022ZAK-2000January 22, 1998
K934689LOW AIR LOSS MATTRESS, MODIFICATIONFebruary 2, 1994
K921500CENTRI-SAFE(TM) VALVESeptember 15, 1992
K882177ADD-ON TO CRITICAL PATIENT CARE BEDDecember 1, 1988
K852736BAYLOR RAPID AUTOTRANSFUSION SYSTEMSeptember 18, 1985
K792152CARDIOPLEGIA SOLUTION ADMIN. SETNovember 13, 1979
K792151OXYGENATOR GAS LINE FILTERNovember 13, 1979