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FDA 510(k)

APRO 35 Swift Catheter and Alembic Aspiration Tubing

K-Number: K262391 · 2026-08-12

ApplicantAlembic, LLC
Decision Date2026-08-12
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APRO 35 Swift Catheter and Alembic Aspiration Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Alembic, LLC. It received FDA 510(k) clearance on 2026-08-12 under 510(k) number K262391. 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 APRO 35 Swift Catheter and Alembic Aspiration Tubing?

APRO 35 Swift Catheter and Alembic Aspiration Tubing is a medical device that received FDA 510(k) clearance on 2026-08-12. The listed applicant is Alembic, LLC. The 510(k) number is K262391.

When did APRO 35 Swift Catheter and Alembic Aspiration Tubing receive FDA 510(k) clearance?

APRO 35 Swift Catheter and Alembic Aspiration Tubing received FDA 510(k) clearance on 2026-08-12, under 510(k) number K262391.

Who is the listed applicant for APRO 35 Swift Catheter and Alembic Aspiration Tubing?

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

What is the FDA product code for APRO 35 Swift Catheter and Alembic Aspiration Tubing?

The FDA product code for APRO 35 Swift Catheter and Alembic Aspiration Tubing is NRY.

Other records listing Alembic, LLC as applicant

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.

K262392APRO 35 Swift CatheterK251014APRO 45 CatheterK251015APRO 45 Catheter and Alembic Aspiration TubingK250962APRO 55 Intermediate CatheterK250958APRO 55 Swift Catheter and Alembic Aspiration TubingK243287APRO 70 Swift Catheter and Alembic Aspiration Tubing

View all 12 devices →

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.K260002Socrates 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 LimitedK254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.

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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