510(k) K031274
K031274 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MODEL 5071 MYOCARDIAL PACING LEAD". The FDA issued a decision of ST on May 22, 2003. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Medtronic Vascular has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- May 22, 2003
- Date Received
- April 22, 2003
- Clearance Type
- Special
- 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