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FDA 510(k)

Ebony HP PTA OTW 0.035 Catheter

K-Number: K220410 · 2022-06-29

ApplicantNatec Medical , Ltd.
Decision Date2022-06-29
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ebony HP PTA OTW 0.035 Catheter is a medical device manufactured by Natec Medical , Ltd.. It received FDA 510(k) clearance on 2022-06-29 under approval number K220410. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ebony HP PTA OTW 0.035 Catheter?

Ebony HP PTA OTW 0.035 Catheter is a medical device that received FDA 510(k) clearance on 2022-06-29. It is manufactured by Natec Medical , Ltd.. The 510(k) number is K220410.

When was Ebony HP PTA OTW 0.035 Catheter approved by the FDA?

Ebony HP PTA OTW 0.035 Catheter received FDA 510(k) clearance on 2022-06-29, under approval number K220410.

What company makes Ebony HP PTA OTW 0.035 Catheter?

Ebony HP PTA OTW 0.035 Catheter is manufactured by Natec Medical , Ltd..

What is the FDA product code for Ebony HP PTA OTW 0.035 Catheter?

The FDA product code for Ebony HP PTA OTW 0.035 Catheter is LIT.

Other Devices by Natec Medical , Ltd.

K210012Tamarin Blue PTCA RX Dilatation Catheter K241040Amethyst HP PTA OTW 0.035 Catheter K251915Amethyst HP PTA OTW 0.035 Catheter

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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.

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