K930476 is an FDA 510(k) clearance for the GUIDING CATHETER. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on February 10, 1994, 377 days after receiving the submission on January 29, 1993.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K930476 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1993 |
| Decision Date | February 10, 1994 |
| Days to Decision | 377 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |