FDA 510(k)

Vessel Dilator

K-Number: K163524 · 2017-06-29

Decision Date2017-06-29

Product CodeDWP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Vessel Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Fetzer Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2017-06-29 under 510(k) number K163524. 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 Vessel Dilator?

Vessel Dilator is a medical device that received FDA 510(k) clearance on 2017-06-29. The listed applicant is Fetzer Medical GmbH & Co. KG. The 510(k) number is K163524.

When did Vessel Dilator receive FDA 510(k) clearance?

Vessel Dilator received FDA 510(k) clearance on 2017-06-29, under 510(k) number K163524.

Who is the listed applicant for Vessel Dilator?

The FDA 510(k) record lists Fetzer Medical GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vessel Dilator?

The FDA product code for Vessel Dilator is DWP.

Other records listing Fetzer Medical GmbH & Co. KG 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.

K172661Fetzer Medical Gynecological Forceps K161004Self-retaining Retractor

Related Devices (Code: DWP)

K220981SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeFehling Surgical Instruments, Inc.K183438Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co.

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.