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 a medical device manufactured by Alembic, LLC. It received FDA 510(k) clearance on 2025-01-14 under approval 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. It is manufactured by Alembic, LLC. The 510(k) number is K243297.
When was APRO 70 Swift Catheter approved by the FDA?
APRO 70 Swift Catheter received FDA 510(k) clearance on 2025-01-14, under approval number K243297.
What company makes APRO 70 Swift Catheter?
APRO 70 Swift Catheter is manufactured by Alembic, LLC.
What is the FDA product code for APRO 70 Swift Catheter?
The FDA product code for APRO 70 Swift Catheter is QJP.
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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.