K000409 is an FDA 510(k) clearance for the MODIFICATION TO T-REX BIOPSY FORCEPS. This device is classified as a Device, Biopsy, Endomyocardial (Class II - Special Controls, product code DWZ).
Submitted by Boston Scientific Corp (Redmond, US). The FDA issued a Cleared decision on February 28, 2000, 20 days after receiving the submission on February 8, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4075.
| 510(k) Number | K000409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2000 |
| Decision Date | February 28, 2000 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWZ — Device, Biopsy, Endomyocardial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4075 |