510(k) K003072
K003072 is an FDA 510(k) premarket notification submitted by Biotronik, Inc. for the device "PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES". The FDA issued a decision of Substantially Equivalent on January 9, 2001. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Biotronik, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2001
- Date Received
- October 3, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Permanent Pacemaker Electrode
- Device Class
- Class III
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type