Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Smec with 7 510(k) clearances. The most recent is a 510(k) clearance dated Dec 11, 1985: PRESSURE TRIGGER MOD OF SMEC INTRA-AORT.
| Date | Record | Source |
|---|---|---|
| Dec 11, 1985 | PRESSURE TRIGGER MOD OF SMEC INTRA-AORTK840367 · DSP | 510(k) clearances |
| Feb 1, 1985 | MODIFIED SMEC PERCUTANEOUS INTRA-AORTICK840037 · DSP | 510(k) clearances |
| Oct 13, 1984 | PERCUTANEOUS BALLOONK832753 · DSP | 510(k) clearances |
| Feb 18, 1983 | INTRA-AORTIC BALLOON SYSTEMK823739 · DSP | 510(k) clearances |
| Dec 15, 1982 | SMEC BALLOON SYSTEMK823177 · DSP | 510(k) clearances |
| Jul 2, 1982 | MODIFICATION OF THE PERCUTAN-BALLOONK813355 · DSP | 510(k) clearances |
| May 14, 1980 | SMEC BALLOON CANNULAK790755 · DSP | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
