510(k) K973818
K973818 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "T-REX BIOPSY FORCEPS". The FDA issued a decision of Substantially Equivalent on December 16, 1997. The device falls under product code DWZ (Device, Biopsy, Endomyocardial), a Class II device regulated under 21 CFR 870.4075. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 1997
- Date Received
- October 7, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Biopsy, Endomyocardial
- Device Class
- Class II
- Regulation Number
- 870.4075
- Review Panel
- CV
- Submission Type