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FDA 510(k)

ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER

K-Number: K002676 · 2000-10-30

ApplicantGuidant Cardiac and Vascular Surgery
Decision Date2000-10-30
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER 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 2000-10-30 under 510(k) number K002676. 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 ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER?

ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER is a medical device that received FDA 510(k) clearance on 2000-10-30. The listed applicant is Guidant Cardiac and Vascular Surgery. The 510(k) number is K002676.

When did ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER receive FDA 510(k) clearance?

ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER received FDA 510(k) clearance on 2000-10-30, under 510(k) number K002676.

Who is the listed applicant for ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER?

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 ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER?

The FDA product code for ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER is DYB.

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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.

K003889ANCURE SHEATH MODEL # 40315, 40320, 40325K001694GUIDANT RETRIEVER DEVICEK003495ANCURE LLIAC BALLOON CATHETERK970470EVT EXPANDABLE SHEATHK970469EVT ANGIOSCALE ANGIOGRAPHIC CATHETERK970608EVT MARKER BOARD

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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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