510(k) K852236
K852236 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC MODEL 5867-1A". The FDA issued a decision of Substantially Equivalent on July 11, 1985. The device falls under product code KFJ (Materials, Repair Or Replacement, Pacemaker), a Class III device regulated under 21 CFR 870.3710. Medtronic Vascular has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1985
- Date Received
- May 22, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Materials, Repair Or Replacement, Pacemaker
- Device Class
- Class III
- Regulation Number
- 870.3710
- Review Panel
- CV
- Submission Type