FDA 510(k)

APRO 45 Catheter

K-Number: K251014 · 2025-05-01

Decision Date2025-05-01

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

APRO 45 Catheter is a medical device manufactured by Alembic, LLC. It received FDA 510(k) clearance on 2025-05-01 under approval number K251014. 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 45 Catheter?

APRO 45 Catheter is a medical device that received FDA 510(k) clearance on 2025-05-01. It is manufactured by Alembic, LLC. The 510(k) number is K251014.

When was APRO 45 Catheter approved by the FDA?

APRO 45 Catheter received FDA 510(k) clearance on 2025-05-01, under approval number K251014.

What company makes APRO 45 Catheter?

APRO 45 Catheter is manufactured by Alembic, LLC.

What is the FDA product code for APRO 45 Catheter?

The FDA product code for APRO 45 Catheter is DQY.

Other Devices by Alembic, LLC

K230695APRO 70 Catheter and Alembic Aspiration Tubing K223545APRO 70 Catheter and Alembic Aspiration Tubing K234115APRO 55 Catheter K232971APRO 55 Catheter and Alembic Aspiration Tubing K251015APRO 45 Catheter and Alembic Aspiration Tubing K250962APRO 55 Intermediate Catheter

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Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire 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.