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FDA 510(k)

Lim Precision Steerable TS, Steerable Sheath, Dilator

K-Number: K202226 · 2020-12-15

ApplicantKeystone Heart, Ltd.
Decision Date2020-12-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Lim Precision Steerable TS, Steerable Sheath, Dilator is a medical device manufactured by Keystone Heart, Ltd.. It received FDA 510(k) clearance on 2020-12-15 under approval number K202226. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lim Precision Steerable TS, Steerable Sheath, Dilator?

Lim Precision Steerable TS, Steerable Sheath, Dilator is a medical device that received FDA 510(k) clearance on 2020-12-15. It is manufactured by Keystone Heart, Ltd.. The 510(k) number is K202226.

When was Lim Precision Steerable TS, Steerable Sheath, Dilator approved by the FDA?

Lim Precision Steerable TS, Steerable Sheath, Dilator received FDA 510(k) clearance on 2020-12-15, under approval number K202226.

What company makes Lim Precision Steerable TS, Steerable Sheath, Dilator?

Lim Precision Steerable TS, Steerable Sheath, Dilator is manufactured by Keystone Heart, Ltd..

What is the FDA product code for Lim Precision Steerable TS, Steerable Sheath, Dilator?

The FDA product code for Lim Precision Steerable TS, Steerable Sheath, Dilator is DYB.

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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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