510(k) K072770
K072770 is an FDA 510(k) premarket notification submitted by Oscor, Inc. for the device "TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)". The FDA issued a decision of Substantially Equivalent on January 22, 2008. The device falls under product code LDF (Electrode, Pacemaker, Temporary), a Class II device regulated under 21 CFR 870.3680. Oscor, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2008
- Date Received
- September 28, 2007
- 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