Next Generation 088 Catheter
K-Number: K254223 · 2026-04-16
ApplicantBalt USA, LLC
Decision Date2026-04-16
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Next Generation 088 Catheter is a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2026-04-16 under approval number K254223. 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 Next Generation 088 Catheter?
Next Generation 088 Catheter is a medical device that received FDA 510(k) clearance on 2026-04-16. It is manufactured by Balt USA, LLC. The 510(k) number is K254223.
When was Next Generation 088 Catheter approved by the FDA?
Next Generation 088 Catheter received FDA 510(k) clearance on 2026-04-16, under approval number K254223.
What company makes Next Generation 088 Catheter?
Next Generation 088 Catheter is manufactured by Balt USA, LLC.
What is the FDA product code for Next Generation 088 Catheter?
The FDA product code for Next Generation 088 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.