510(k) K961336

MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652 by Medtronic PS Medical — Product Code LJS

K961336 is an FDA 510(k) premarket notification submitted by Medtronic PS Medical for the device "MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652". The FDA issued a decision of Substantially Equivalent on July 18, 1996. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Medtronic PS Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1996
Date Received
April 8, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type