The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for T-rex Biopsy Forceps.
| Device ID | K973818 |
| 510k Number | K973818 |
| Device Name: | T-REX BIOPSY FORCEPS |
| Classification | Device, Biopsy, Endomyocardial |
| Applicant | BOSTON SCIENTIFIC CORP. 17425 NORTH EAST UNION HILL RD NORTHWEST TECHNOLOGY CENTER Redmond, WA 98052 -3376 |
| Contact | Jocelyn Kersten |
| Correspondent | Jocelyn Kersten BOSTON SCIENTIFIC CORP. 17425 NORTH EAST UNION HILL RD NORTHWEST TECHNOLOGY CENTER Redmond, WA 98052 -3376 |
| Product Code | DWZ |
| CFR Regulation Number | 870.4075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-07 |
| Decision Date | 1997-12-16 |
| Summary: | summary |