Gem FlowCoupler System
K-Number: K190499 · 2019-09-06
Decision Date2019-09-06
Product CodeMVR
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Gem FlowCoupler System is a medical device manufactured by Baxter/ Synovis Micro Companies Alliance, Inc.. It received FDA 510(k) clearance on 2019-09-06 under approval number K190499. The device is classified under product code MVR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Gem FlowCoupler System?
Gem FlowCoupler System is a medical device that received FDA 510(k) clearance on 2019-09-06. It is manufactured by Baxter/ Synovis Micro Companies Alliance, Inc.. The 510(k) number is K190499.
When was Gem FlowCoupler System approved by the FDA?
Gem FlowCoupler System received FDA 510(k) clearance on 2019-09-06, under approval number K190499.
What company makes Gem FlowCoupler System?
Gem FlowCoupler System is manufactured by Baxter/ Synovis Micro Companies Alliance, Inc..
What is the FDA product code for Gem FlowCoupler System?
The FDA product code for Gem FlowCoupler System is MVR.
Other Devices by Baxter/ Synovis Micro Companies Alliance, Inc.
Related Devices (Code: MVR)
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.