Optima Coil System
K-Number: K172390 · 2018-02-18
Decision Date2018-02-18
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Optima Coil System is a medical device manufactured by Blockade Medical, LLC (D.B.A. Balt Usa). It received FDA 510(k) clearance on 2018-02-18 under approval number K172390. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Optima Coil System?
Optima Coil System is a medical device that received FDA 510(k) clearance on 2018-02-18. It is manufactured by Blockade Medical, LLC (D.B.A. Balt Usa). The 510(k) number is K172390.
When was Optima Coil System approved by the FDA?
Optima Coil System received FDA 510(k) clearance on 2018-02-18, under approval number K172390.
What company makes Optima Coil System?
Optima Coil System is manufactured by Blockade Medical, LLC (D.B.A. Balt Usa).
What is the FDA product code for Optima Coil System?
The FDA product code for Optima Coil System is HCG.
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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.