K891121 is an FDA 510(k) clearance for the MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on December 5, 1989, 278 days after receiving the submission on March 2, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K891121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1989 |
| Decision Date | December 05, 1989 |
| Days to Decision | 278 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |