K890453 is an FDA 510(k) clearance for the REUSABLE MLYOCARDIAL BIOPSY FORCEPS (BIOPTOMES. This device is classified as a Device, Biopsy, Endomyocardial (Class II - Special Controls, product code DWZ).
Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on March 31, 1989, 60 days after receiving the submission on January 30, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4075.
| 510(k) Number | K890453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 1989 |
| Decision Date | March 31, 1989 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DWZ — Device, Biopsy, Endomyocardial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4075 |