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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 a medical device manufactured by Alembic, LLC. It received FDA 510(k) clearance on 2025-04-29 under approval 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. It is manufactured by Alembic, LLC. The 510(k) number is K250962.

When was APRO 55 Intermediate Catheter approved by the FDA?

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

What company makes APRO 55 Intermediate Catheter?

APRO 55 Intermediate Catheter is manufactured by Alembic, LLC.

What is the FDA product code for APRO 55 Intermediate Catheter?

The FDA product code for APRO 55 Intermediate Catheter is DQY.

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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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