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FDA 510(k)

ANCURE SHEATH MODEL # 40315, 40320, 40325

K-Number: K003889 · 2002-01-24

ApplicantGuidant Cardiac and Vascular Surgery
Decision Date2002-01-24
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANCURE SHEATH MODEL # 40315, 40320, 40325 is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Cardiac and Vascular Surgery. It received FDA 510(k) clearance on 2002-01-24 under 510(k) number K003889. 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 ANCURE SHEATH MODEL # 40315, 40320, 40325?

ANCURE SHEATH MODEL # 40315, 40320, 40325 is a medical device that received FDA 510(k) clearance on 2002-01-24. The listed applicant is Guidant Cardiac and Vascular Surgery. The 510(k) number is K003889.

When did ANCURE SHEATH MODEL # 40315, 40320, 40325 receive FDA 510(k) clearance?

ANCURE SHEATH MODEL # 40315, 40320, 40325 received FDA 510(k) clearance on 2002-01-24, under 510(k) number K003889.

Who is the listed applicant for ANCURE SHEATH MODEL # 40315, 40320, 40325?

The FDA 510(k) record lists Guidant Cardiac and Vascular Surgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANCURE SHEATH MODEL # 40315, 40320, 40325?

The FDA product code for ANCURE SHEATH MODEL # 40315, 40320, 40325 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.

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Other records listing Guidant Cardiac and Vascular Surgery 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.

K001694GUIDANT RETRIEVER DEVICEK003495ANCURE LLIAC BALLOON CATHETERK002676ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCERK970470EVT EXPANDABLE SHEATHK970469EVT ANGIOSCALE ANGIOGRAPHIC CATHETERK970608EVT MARKER BOARD

View all 7 devices →

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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