Smec, Inc. - FDA 510(k) Cleared Devices
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Smec, Inc. Cardiovascular ✕
7 devices
Cleared
Dec 11, 1985
PRESSURE TRIGGER MOD OF SMEC INTRA-AORT
Cardiovascular
684d
Cleared
Feb 01, 1985
MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC
Cardiovascular
393d
Cleared
Oct 13, 1984
PERCUTANEOUS BALLOON
Cardiovascular
425d
Cleared
Feb 18, 1983
INTRA-AORTIC BALLOON SYSTEM
Cardiovascular
67d
Cleared
Dec 15, 1982
SMEC BALLOON SYSTEM
Cardiovascular
50d
Cleared
Jul 02, 1982
MODIFICATION OF THE PERCUTAN-BALLOON
Cardiovascular
217d
Cleared
May 14, 1980
SMEC BALLOON CANNULA
Cardiovascular
393d