510(k) K252390

Telescope Guide Extension Catheter by Medtronic, Ireland — Product Code DQY

K252390 is an FDA 510(k) premarket notification submitted by Medtronic, Ireland for the device "Telescope Guide Extension Catheter". The FDA issued a decision of Substantially Equivalent on October 29, 2025. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Medtronic, Ireland has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2025
Date Received
July 31, 2025
Clearance Type
Traditional
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