510(k) K000210
K000210 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT". The FDA issued a decision of ST on February 23, 2000. The device falls under product code DTD (Pacemaker Lead Adaptor), a Class II device regulated under 21 CFR 870.3620. Medtronic Vascular has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- February 23, 2000
- Date Received
- January 24, 2000
- Clearance Type
- Special
- 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