Company ยท US
Smec, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1985. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 11, 1985 | K840367 | PRESSURE TRIGGER MOD OF SMEC INTRA-AORT Smec, Inc. | DSP |
| Feb 1, 1985 | K840037 | MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC Smec, Inc. | DSP |
| Oct 13, 1984 | K832753 | PERCUTANEOUS BALLOON Smec, Inc. | DSP |
| Feb 18, 1983 | K823739 | INTRA-AORTIC BALLOON SYSTEM Smec, Inc. | DSP |
| Dec 15, 1982 | K823177 | SMEC BALLOON SYSTEM Smec, Inc. | DSP |
| Jul 2, 1982 | K813355 | MODIFICATION OF THE PERCUTAN-BALLOON Smec, Inc. | DSP |
| May 14, 1980 | K790755 | SMEC BALLOON CANNULA Smec, Inc. | DSP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||