510(k) K982220
K982220 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MODEL 2872 BIPOLAR LEAD ADAPTOR KIT". The FDA issued a decision of ST on October 15, 1998. 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
- October 15, 1998
- Date Received
- June 24, 1998
- Clearance Type
- Traditional
- 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