Cleared Traditional

C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)

K253409 · Medtronic, Inc. · Cardiovascular

Dec 2025

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K253409 is an FDA 510(k) clearance for the C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48), a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on December 19, 2025, 80 days after receiving the submission on September 30, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K253409 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2025
Decision Date	December 19, 2025
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF