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FDA 510(k)

CORDIS AVIATOR PERIPHERAL DILATATION CATHETER

K-Number: K013581 · 2001-11-28

ApplicantCordis, A Johnson & Johnson Co.
Decision Date2001-11-28
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIS AVIATOR PERIPHERAL DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cordis, A Johnson & Johnson Co.. It received FDA 510(k) clearance on 2001-11-28 under 510(k) number K013581. 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 CORDIS AVIATOR PERIPHERAL DILATATION CATHETER?

CORDIS AVIATOR PERIPHERAL DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2001-11-28. The listed applicant is Cordis, A Johnson & Johnson Co.. The 510(k) number is K013581.

When did CORDIS AVIATOR PERIPHERAL DILATATION CATHETER receive FDA 510(k) clearance?

CORDIS AVIATOR PERIPHERAL DILATATION CATHETER received FDA 510(k) clearance on 2001-11-28, under 510(k) number K013581.

Who is the listed applicant for CORDIS AVIATOR PERIPHERAL DILATATION CATHETER?

The FDA 510(k) record lists Cordis, A Johnson & Johnson Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORDIS AVIATOR PERIPHERAL DILATATION CATHETER?

The FDA product code for CORDIS AVIATOR PERIPHERAL DILATATION CATHETER is DQY.

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Other records listing Cordis, A Johnson & Johnson Co. 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.

K012090CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENTK992755CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE

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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