510(k) K965251

MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM by Medtronic Vascular — Product Code MAJ

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