Medtronic, Inc. · Class II · Cleared Dec 19, 2025
| K-number | K253409 |
| Device name | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) |
| Applicant | Medtronic, Inc. |
| Product code | DQY |
| Device class | Class II |
| Decision date | Dec 19, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
The C320LBB Delivery System is a single-use, disposable catheter with an integrated hemostasis valve and radiopaque marker bands designed to aid in introducing and placing cardiac leads into the right chambers of the heart. It is intended for patients indicated for cardiac implantable electronic devices (CIEDs) to treat heart rhythm disorders.
The C320LBB has two distinct curve shapes (large and small) designed to reach the Left Bundle Branch Area (LBBA), which differ from the C315 predicate device's curve shapes. The device uses braid and Vestamid materials referenced from the Attain Select II catheter, with differences in materials and dimensions compared to the predicate.
Not stated in this summary.
The C320LBB uses similar technology and has the same indications for use, similar function, materials, and method of operation as the C315 Delivery Catheter predicate device (K250558). Device integrity testing including mechanical, functional, and biocompatibility testing met all specified design and performance requirements, supporting substantial equivalence.
View the full FDA submission: accessdata.fda.gov