APRO 55 Catheter
K-Number: K234115 · 2024-03-15
ApplicantAlembic, LLC
Decision Date2024-03-15
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
APRO 55 Catheter is a medical device manufactured by Alembic, LLC. It received FDA 510(k) clearance on 2024-03-15 under approval number K234115. 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 Catheter?
APRO 55 Catheter is a medical device that received FDA 510(k) clearance on 2024-03-15. It is manufactured by Alembic, LLC. The 510(k) number is K234115.
When was APRO 55 Catheter approved by the FDA?
APRO 55 Catheter received FDA 510(k) clearance on 2024-03-15, under approval number K234115.
What company makes APRO 55 Catheter?
APRO 55 Catheter is manufactured by Alembic, LLC.
What is the FDA product code for APRO 55 Catheter?
The FDA product code for APRO 55 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.