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FDA 510(k)

ANCURE LLIAC BALLOON CATHETER

K-Number: K003495 · 2001-02-07

ApplicantGuidant Cardiac and Vascular Surgery
Decision Date2001-02-07
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANCURE LLIAC BALLOON CATHETER 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 2001-02-07 under 510(k) number K003495. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANCURE LLIAC BALLOON CATHETER?

ANCURE LLIAC BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2001-02-07. The listed applicant is Guidant Cardiac and Vascular Surgery. The 510(k) number is K003495.

When did ANCURE LLIAC BALLOON CATHETER receive FDA 510(k) clearance?

ANCURE LLIAC BALLOON CATHETER received FDA 510(k) clearance on 2001-02-07, under 510(k) number K003495.

Who is the listed applicant for ANCURE LLIAC BALLOON CATHETER?

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 LLIAC BALLOON CATHETER?

The FDA product code for ANCURE LLIAC BALLOON CATHETER is DQY.

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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 DEVICEK002676ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCERK970470EVT EXPANDABLE SHEATHK970469EVT ANGIOSCALE ANGIOGRAPHIC CATHETERK970608EVT MARKER BOARD

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Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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