510(k) K160260
K160260 is an FDA 510(k) premarket notification submitted by Biotrace Medical, Inc. for the device "Tempo Temporary Pacing Lead". The FDA issued a decision of Substantially Equivalent on Oct 25, 2016. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 25, 2016
- Date Received
- Feb 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Electrode, Pacemaker, Temporary
- Device Class
- Class II
- Regulation Number
- 870.3680
- Review Panel
- CV
- Submission Type
- 510(k)