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FDA 510(k)

M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER

K-Number: K112100 · 2012-03-20

ApplicantVascular Solutions, Inc.
Decision Date2012-03-20
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2012-03-20 under 510(k) number K112100. 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 M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER?

M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER is a medical device that received FDA 510(k) clearance on 2012-03-20. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K112100.

When did M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER receive FDA 510(k) clearance?

M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER received FDA 510(k) clearance on 2012-03-20, under 510(k) number K112100.

Who is the listed applicant for M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER?

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

What is the FDA product code for M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER?

The FDA product code for M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER is DQY.

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Other records listing Vascular Solutions, Inc. as applicant

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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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