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FDA 510(k)

APRO 35 Swift Catheter

K-Number: K262392 · 2026-08-12

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

Device Summary

APRO 35 Swift Catheter 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 K262392. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APRO 35 Swift Catheter?

APRO 35 Swift Catheter 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 K262392.

When did APRO 35 Swift Catheter receive FDA 510(k) clearance?

APRO 35 Swift Catheter received FDA 510(k) clearance on 2026-08-12, under 510(k) number K262392.

Who is the listed applicant for APRO 35 Swift Catheter?

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?

The FDA product code for APRO 35 Swift Catheter is DQY.

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.

K262391APRO 35 Swift Catheter and Alembic Aspiration TubingK251014APRO 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

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Related Devices (Code: DQY)

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.

K260559NHanceITIMDS Operation B.V.K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott MedicalK260289Perfect-O Ostial Positioning CatheterBalosmark, 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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