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FDA 510(k)

EXTesia Introducer Sheath Set

K-Number: K220604 · 2022-04-27

ApplicantCuratia Medical Co.
Decision Date2022-04-27
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTesia Introducer Sheath Set is the device name listed in this FDA 510(k) record. The listed applicant is Curatia Medical Co.. It received FDA 510(k) clearance on 2022-04-27 under 510(k) number K220604. 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 EXTesia Introducer Sheath Set?

EXTesia Introducer Sheath Set is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Curatia Medical Co.. The 510(k) number is K220604.

When did EXTesia Introducer Sheath Set receive FDA 510(k) clearance?

EXTesia Introducer Sheath Set received FDA 510(k) clearance on 2022-04-27, under 510(k) number K220604.

Who is the listed applicant for EXTesia Introducer Sheath Set?

The FDA 510(k) record lists Curatia Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTesia Introducer Sheath Set?

The FDA product code for EXTesia Introducer Sheath Set is DYB.

Other records listing Curatia Medical Co. as applicant

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.

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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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