K973818 is an FDA 510(k) clearance for the 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 December 16, 1997, 70 days after receiving the submission on October 7, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4075.
| 510(k) Number | K973818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1997 |
| Decision Date | December 16, 1997 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| 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 |