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FDA 510(k)

Carrier XL Delivery Catheter

K-Number: K252569 · 2025-10-22

ApplicantBalt USA, LLC
Decision Date2025-10-22
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Carrier XL Delivery Catheter is a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2025-10-22 under approval number K252569. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Carrier XL Delivery Catheter?

Carrier XL Delivery Catheter is a medical device that received FDA 510(k) clearance on 2025-10-22. It is manufactured by Balt USA, LLC. The 510(k) number is K252569.

When was Carrier XL Delivery Catheter approved by the FDA?

Carrier XL Delivery Catheter received FDA 510(k) clearance on 2025-10-22, under approval number K252569.

What company makes Carrier XL Delivery Catheter?

Carrier XL Delivery Catheter is manufactured by Balt USA, LLC.

What is the FDA product code for Carrier XL Delivery Catheter?

The FDA product code for Carrier XL Delivery Catheter is QJP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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