CurvaFix Low Profile System
K-Number: K252019 · 2025-08-29
ApplicantCurvafix, Inc.
Decision Date2025-08-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CurvaFix Low Profile System is a medical device manufactured by Curvafix, Inc.. It received FDA 510(k) clearance on 2025-08-29 under approval number K252019. 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 CurvaFix Low Profile System?
CurvaFix Low Profile System is a medical device that received FDA 510(k) clearance on 2025-08-29. It is manufactured by Curvafix, Inc.. The 510(k) number is K252019.
When was CurvaFix Low Profile System approved by the FDA?
CurvaFix Low Profile System received FDA 510(k) clearance on 2025-08-29, under approval number K252019.
What company makes CurvaFix Low Profile System?
CurvaFix Low Profile System is manufactured by Curvafix, Inc..
What is the FDA product code for CurvaFix Low Profile System?
The FDA product code for CurvaFix Low Profile System is HWC. This falls under the Cardiovascular category.
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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.