510(k) K970204
K970204 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "BK-A; BK-B; BK-IS SEALING CAP". The FDA issued a decision of Substantially Equivalent on April 29, 1997. The device falls under product code DTD (Pacemaker Lead Adaptor), a Class II device regulated under 21 CFR 870.3620. Biotronik, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1997
- Date Received
- January 21, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pacemaker Lead Adaptor
- Device Class
- Class II
- Regulation Number
- 870.3620
- Review Panel
- CV
- Submission Type