510(k) K934939

TEMPORARY SCREENING LEAD/ CATHETER KIT by Medtronic Vascular — Product Code MAJ

K934939 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "TEMPORARY SCREENING LEAD/ CATHETER KIT". The FDA issued a decision of Substantially Equivalent on May 24, 1995. 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
May 24, 1995
Date Received
October 18, 1993
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