CoAptix S System
K-Number: K252699 · 2026-04-10
Decision Date2026-04-10
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CoAptix S System is a medical device manufactured by University of Utah, Department of Orthopaedics. It received FDA 510(k) clearance on 2026-04-10 under approval number K252699. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CoAptix S System?
CoAptix S System is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by University of Utah, Department of Orthopaedics. The 510(k) number is K252699.
When was CoAptix S System approved by the FDA?
CoAptix S System received FDA 510(k) clearance on 2026-04-10, under approval number K252699.
What company makes CoAptix S System?
CoAptix S System is manufactured by University of Utah, Department of Orthopaedics.
What is the FDA product code for CoAptix S System?
The FDA product code for CoAptix S System is HWC. This falls under the Cardiovascular category.
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Official Source
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