K252569

Carrier XL Delivery Catheter

510(k) number
K252569
Device name
Carrier XL Delivery Catheter
Applicant
Balt USA, LLC CA · US
Product code
QJP — Catheter, Percutaneous, Neurovasculature
Decision date
2025-10-22
Date received
2025-08-14
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Cardiovascular
510(k) Summary (official FDA PDF): K252569.pdf
Official FDA record: K252569
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.