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FDA 510(k)

Raptor Aspiration Catheter; Balt Aspiration Tubing Set

K-Number: K243948 · 2025-06-03

ApplicantBalt USA, LLC
Decision Date2025-06-03
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Raptor Aspiration Catheter; Balt Aspiration Tubing Set is the device name listed in this FDA 510(k) record. The listed applicant is Balt USA, LLC. It received FDA 510(k) clearance on 2025-06-03 under 510(k) number K243948. 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 Raptor Aspiration Catheter; Balt Aspiration Tubing Set?

Raptor Aspiration Catheter; Balt Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2025-06-03. The listed applicant is Balt USA, LLC. The 510(k) number is K243948.

When did Raptor Aspiration Catheter; Balt Aspiration Tubing Set receive FDA 510(k) clearance?

Raptor Aspiration Catheter; Balt Aspiration Tubing Set received FDA 510(k) clearance on 2025-06-03, under 510(k) number K243948.

Who is the listed applicant for Raptor Aspiration Catheter; Balt Aspiration Tubing Set?

The FDA 510(k) record lists Balt USA, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Balt USA, LLC as applicant

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Related Devices (Code: NRY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited

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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