510(k) K911302
K911302 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT". The FDA issued a decision of Substantially Equivalent on July 30, 1991. 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
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1991
- Date Received
- March 25, 1991
- 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