510(k) K192296

Medtronic 6F Taiga Guiding Catheter by Medtronic Vascular — Product Code DQY

K192296 is an FDA 510(k) premarket notification submitted by Medtronic Vascular for the device "Medtronic 6F Taiga Guiding Catheter". The FDA issued a decision of Substantially Equivalent on September 20, 2019. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Medtronic Vascular has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2019
Date Received
August 23, 2019
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