FDA 510(k)

Optima Coil System

K-Number: K172390 · 2018-02-18

ApplicantBlockade Medical, LLC (D.B.A. Balt Usa)

Decision Date2018-02-18

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Optima Coil System is the device name listed in this FDA 510(k) record. The listed applicant is Blockade Medical, LLC (D.B.A. Balt Usa). It received FDA 510(k) clearance on 2018-02-18 under 510(k) 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. The listed applicant is Blockade Medical, LLC (D.B.A. Balt Usa). The 510(k) number is K172390.

When did Optima Coil System receive FDA 510(k) clearance?

Optima Coil System received FDA 510(k) clearance on 2018-02-18, under 510(k) number K172390.

Who is the listed applicant for Optima Coil System?

The FDA 510(k) record lists Blockade Medical, LLC (D.B.A. Balt Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optima Coil System?

The FDA product code for Optima Coil System is HCG.

Related Devices (Code: HCG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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