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FDA 510(k)

APRO 55 Intermediate Catheter

K-Number: K250962 · 2025-04-29

ApplicantAlembic, LLC
Decision Date2025-04-29
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APRO 55 Intermediate 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 2025-04-29 under 510(k) number K250962. 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 55 Intermediate Catheter?

APRO 55 Intermediate Catheter is a medical device that received FDA 510(k) clearance on 2025-04-29. The listed applicant is Alembic, LLC. The 510(k) number is K250962.

When did APRO 55 Intermediate Catheter receive FDA 510(k) clearance?

APRO 55 Intermediate Catheter received FDA 510(k) clearance on 2025-04-29, under 510(k) number K250962.

Who is the listed applicant for APRO 55 Intermediate 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 55 Intermediate Catheter?

The FDA product code for APRO 55 Intermediate 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.

K262392APRO 35 Swift CatheterK262391APRO 35 Swift Catheter and Alembic Aspiration TubingK251014APRO 45 CatheterK251015APRO 45 Catheter and Alembic Aspiration TubingK250958APRO 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.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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