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FDA 510(k)

VIA MICROCATHETER, VIA PLUS MICROCATHETER

K-Number: K132652 · 2013-12-20

ApplicantSequent Medical, Inc.
Decision Date2013-12-20
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIA MICROCATHETER, VIA PLUS MICROCATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Sequent Medical, Inc.. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K132652. 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 VIA MICROCATHETER, VIA PLUS MICROCATHETER?

VIA MICROCATHETER, VIA PLUS MICROCATHETER is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Sequent Medical, Inc.. The 510(k) number is K132652.

When did VIA MICROCATHETER, VIA PLUS MICROCATHETER receive FDA 510(k) clearance?

VIA MICROCATHETER, VIA PLUS MICROCATHETER received FDA 510(k) clearance on 2013-12-20, under 510(k) number K132652.

Who is the listed applicant for VIA MICROCATHETER, VIA PLUS MICROCATHETER?

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

What is the FDA product code for VIA MICROCATHETER, VIA PLUS MICROCATHETER?

The FDA product code for VIA MICROCATHETER, VIA PLUS MICROCATHETER 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 Sequent Medical, Inc. 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.

K162565VIA 17 MicrocatheterK123477VIA MICROCATHETER, VIA PLUS MICROCATHETER

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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