SavvyWire
K-Number: K213854 · 2022-09-14
ApplicantOpsens, Inc.
Decision Date2022-09-14
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SavvyWire is a medical device manufactured by Opsens, Inc.. It received FDA 510(k) clearance on 2022-09-14 under approval number K213854. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SavvyWire?
SavvyWire is a medical device that received FDA 510(k) clearance on 2022-09-14. It is manufactured by Opsens, Inc.. The 510(k) number is K213854.
When was SavvyWire approved by the FDA?
SavvyWire received FDA 510(k) clearance on 2022-09-14, under approval number K213854.
What company makes SavvyWire?
SavvyWire is manufactured by Opsens, Inc..
What is the FDA product code for SavvyWire?
The FDA product code for SavvyWire is DQX.
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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.