510(k) K965251
K965251 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on March 18, 1997. The device falls under product code MAJ (Catheter, Percutaneous, Intraspinal, Short Term), a Class II device regulated under 21 CFR 868.5120. Medtronic Vascular has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 1997
- Date Received
- December 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous, Intraspinal, Short Term
- Device Class
- Class II
- Regulation Number
- 868.5120
- Review Panel
- HO
- Submission Type