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FDA 510(k)

VASCULAR PROBE, VASCULAR PROBE ES

K-Number: K130896 · 2013-04-24

Decision Date2013-04-24
Product CodeDWP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCULAR PROBE, VASCULAR PROBE ES is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Life Technologies, Inc.. It received FDA 510(k) clearance on 2013-04-24 under 510(k) number K130896. The device is classified under product code DWP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCULAR PROBE, VASCULAR PROBE ES?

VASCULAR PROBE, VASCULAR PROBE ES is a medical device that received FDA 510(k) clearance on 2013-04-24. The listed applicant is Synovis Life Technologies, Inc.. The 510(k) number is K130896.

When did VASCULAR PROBE, VASCULAR PROBE ES receive FDA 510(k) clearance?

VASCULAR PROBE, VASCULAR PROBE ES received FDA 510(k) clearance on 2013-04-24, under 510(k) number K130896.

Who is the listed applicant for VASCULAR PROBE, VASCULAR PROBE ES?

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

What is the FDA product code for VASCULAR PROBE, VASCULAR PROBE ES?

The FDA product code for VASCULAR PROBE, VASCULAR PROBE ES is DWP.

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.

Other records listing Synovis Life Technologies, 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.

Related Devices (Code: DWP)

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.

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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