K983744 is an FDA 510(k) clearance for the MCAS (MODULAR CLIP APPLIER SYSTEM). This device is classified as a Clip, Vascular (Class II - Special Controls, product code DSS).
Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on January 21, 1999, 90 days after receiving the submission on October 23, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3250.
| 510(k) Number | K983744 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1998 |
| Decision Date | January 21, 1999 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSS — Clip, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3250 |