Kii Structural Balloon Access System
K-Number: K252442 · 2025-10-31
ApplicantApplied Medical Resources Corp.
Decision Date2025-10-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Kii Structural Balloon Access System is a medical device manufactured by Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2025-10-31 under approval number K252442. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Kii Structural Balloon Access System?
Kii Structural Balloon Access System is a medical device that received FDA 510(k) clearance on 2025-10-31. It is manufactured by Applied Medical Resources Corp.. The 510(k) number is K252442.
When was Kii Structural Balloon Access System approved by the FDA?
Kii Structural Balloon Access System received FDA 510(k) clearance on 2025-10-31, under approval number K252442.
What company makes Kii Structural Balloon Access System?
Kii Structural Balloon Access System is manufactured by Applied Medical Resources Corp..
What is the FDA product code for Kii Structural Balloon Access System?
The FDA product code for Kii Structural Balloon Access System is GCJ.
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Related PubMed Literature
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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.