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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 the device name listed in this FDA 510(k) record. The listed applicant is Keystone Heart, Ltd.. It received FDA 510(k) clearance on 2020-12-15 under 510(k) 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. The listed applicant is Keystone Heart, Ltd.. The 510(k) number is K202226.

When did Lim Precision Steerable TS, Steerable Sheath, Dilator receive FDA 510(k) clearance?

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

Who is the listed applicant for Lim Precision Steerable TS, Steerable Sheath, Dilator?

The FDA 510(k) record lists Keystone Heart, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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