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FDA 510(k)

APRO 88 Catheter

K-Number: K261938 · 2026-10-06

ApplicantAlembic, LLC
Decision Date2026-10-06
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

APRO 88 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 2026-10-06 under 510(k) number K261938. 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 88 Catheter?

APRO 88 Catheter is a medical device that received FDA 510(k) clearance on 2026-10-06. The listed applicant is Alembic, LLC. The 510(k) number is K261938.

When did APRO 88 Catheter receive FDA 510(k) clearance?

APRO 88 Catheter received FDA 510(k) clearance on 2026-10-06, under 510(k) number K261938.

Who is the listed applicant for APRO 88 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 88 Catheter?

The FDA product code for APRO 88 Catheter is QJP.

Related Clinical Trials

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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 TubingK262392APRO 35 Swift CatheterK251014APRO 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.

K261649Excelsior Reach MicrocatheterStryker NeurovascularK253422OAB Delivery CatheterCognition Medical Corp.K260220Route 92 Medical Full Length 046 Access SystemRoute 92 Medical, Inc.K26227770 NeuGlide CatheterPiraeus Medical, Inc.K261176Zoom 4S CatheterImperative Care, Inc.K254071p17 XR MicrocatheterWallaby 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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