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FDA 510(k)

Next Generation Aspiration Catheter; Balt Aspiration Tubing Set

K-Number: K234083 · 2024-07-02

ApplicantBalt USA, LLC
Decision Date2024-07-02
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Next Generation Aspiration Catheter; Balt Aspiration Tubing Set is a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2024-07-02 under approval number K234083. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Next Generation Aspiration Catheter; Balt Aspiration Tubing Set?

Next Generation Aspiration Catheter; Balt Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2024-07-02. It is manufactured by Balt USA, LLC. The 510(k) number is K234083.

When was Next Generation Aspiration Catheter; Balt Aspiration Tubing Set approved by the FDA?

Next Generation Aspiration Catheter; Balt Aspiration Tubing Set received FDA 510(k) clearance on 2024-07-02, under approval number K234083.

What company makes Next Generation Aspiration Catheter; Balt Aspiration Tubing Set?

Next Generation Aspiration Catheter; Balt Aspiration Tubing Set is manufactured by Balt USA, LLC.

What is the FDA product code for Next Generation Aspiration Catheter; Balt Aspiration Tubing Set?

The FDA product code for Next Generation Aspiration Catheter; Balt Aspiration Tubing Set is NRY.

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Related Devices (Code: NRY)

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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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