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FDA 510(k)

APRO 70 Swift Catheter

K-Number: K243297 · 2025-01-14

ApplicantAlembic, LLC
Decision Date2025-01-14
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APRO 70 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 2025-01-14 under 510(k) number K243297. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APRO 70 Swift Catheter?

APRO 70 Swift Catheter is a medical device that received FDA 510(k) clearance on 2025-01-14. The listed applicant is Alembic, LLC. The 510(k) number is K243297.

When did APRO 70 Swift Catheter receive FDA 510(k) clearance?

APRO 70 Swift Catheter received FDA 510(k) clearance on 2025-01-14, under 510(k) number K243297.

Who is the listed applicant for APRO 70 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 70 Swift Catheter?

The FDA product code for APRO 70 Swift Catheter is QJP.

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 TubingK250962APRO 55 Intermediate CatheterK250958APRO 55 Swift Catheter and Alembic Aspiration Tubing

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Related Devices (Code: QJP)

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.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou 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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