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FDA 510(k)

VASCON POLARIS GUIDING CATHETER

K-Number: K033633 · 2004-02-18

ApplicantVascon, LLC
Decision Date2004-02-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCON POLARIS GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vascon, LLC. It received FDA 510(k) clearance on 2004-02-18 under 510(k) number K033633. 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 VASCON POLARIS GUIDING CATHETER?

VASCON POLARIS GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 2004-02-18. The listed applicant is Vascon, LLC. The 510(k) number is K033633.

When did VASCON POLARIS GUIDING CATHETER receive FDA 510(k) clearance?

VASCON POLARIS GUIDING CATHETER received FDA 510(k) clearance on 2004-02-18, under 510(k) number K033633.

Who is the listed applicant for VASCON POLARIS GUIDING CATHETER?

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

What is the FDA product code for VASCON POLARIS GUIDING CATHETER?

The FDA product code for VASCON POLARIS GUIDING CATHETER is DQY.

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 Vascon, LLC 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.

K053310VASCON ROAMER MICROCATHETERK052004VASCON NEUROPATH GUIDING CATHETERK043387VASCON POLARIS GUIDING CATHETER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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