InFrame Cannulated Fixation System
K-Number: K201430 · 2020-06-20
ApplicantExsomed Corp.
Decision Date2020-06-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
InFrame Cannulated Fixation System is a medical device manufactured by Exsomed Corp.. It received FDA 510(k) clearance on 2020-06-20 under approval number K201430. 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 InFrame Cannulated Fixation System?
InFrame Cannulated Fixation System is a medical device that received FDA 510(k) clearance on 2020-06-20. It is manufactured by Exsomed Corp.. The 510(k) number is K201430.
When was InFrame Cannulated Fixation System approved by the FDA?
InFrame Cannulated Fixation System received FDA 510(k) clearance on 2020-06-20, under approval number K201430.
What company makes InFrame Cannulated Fixation System?
InFrame Cannulated Fixation System is manufactured by Exsomed Corp..
What is the FDA product code for InFrame Cannulated Fixation System?
The FDA product code for InFrame Cannulated Fixation 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.