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FDA 510(k)

TEARAWAY INTRODUCER SHEATH

K-Number: K000313 · 2000-06-16

ApplicantXentek Medical, Inc.
Decision Date2000-06-16
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEARAWAY INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Xentek Medical, Inc.. It received FDA 510(k) clearance on 2000-06-16 under 510(k) number K000313. 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 TEARAWAY INTRODUCER SHEATH?

TEARAWAY INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 2000-06-16. The listed applicant is Xentek Medical, Inc.. The 510(k) number is K000313.

When did TEARAWAY INTRODUCER SHEATH receive FDA 510(k) clearance?

TEARAWAY INTRODUCER SHEATH received FDA 510(k) clearance on 2000-06-16, under 510(k) number K000313.

Who is the listed applicant for TEARAWAY INTRODUCER SHEATH?

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

What is the FDA product code for TEARAWAY INTRODUCER SHEATH?

The FDA product code for TEARAWAY INTRODUCER SHEATH is DYB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Xentek Medical, Inc. 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.

K000737COAXIAL DILATOR SET

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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