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FDA 510(k)

VASCUTRAK 2, MODELS: V14 AND V18

K-Number: K082343 · 2008-09-11

ApplicantYmed, Inc.
Decision Date2008-09-11
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCUTRAK 2, MODELS: V14 AND V18 is the device name listed in this FDA 510(k) record. The listed applicant is Ymed, Inc.. It received FDA 510(k) clearance on 2008-09-11 under 510(k) number K082343. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCUTRAK 2, MODELS: V14 AND V18?

VASCUTRAK 2, MODELS: V14 AND V18 is a medical device that received FDA 510(k) clearance on 2008-09-11. The listed applicant is Ymed, Inc.. The 510(k) number is K082343.

When did VASCUTRAK 2, MODELS: V14 AND V18 receive FDA 510(k) clearance?

VASCUTRAK 2, MODELS: V14 AND V18 received FDA 510(k) clearance on 2008-09-11, under 510(k) number K082343.

Who is the listed applicant for VASCUTRAK 2, MODELS: V14 AND V18?

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

What is the FDA product code for VASCUTRAK 2, MODELS: V14 AND V18?

The FDA product code for VASCUTRAK 2, MODELS: V14 AND V18 is PNO.

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 Ymed, 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.

K063657VASCUTRAK PTA DILATION CATHETER

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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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