510(k) K982883

MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER by Medtronics Interventional Vascular — Product Code DQY

K982883 is an FDA 510(k) premarket notification submitted by Medtronics Interventional Vascular for the device "MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER". The FDA issued a decision of Substantially Equivalent on September 4, 1998. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Medtronics Interventional Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1998
Date Received
August 17, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type