FDA 510(k)

Geomed Vascular Dilators

K-Number: K183438 · 2019-09-03

ApplicantGeomed Medizin-Technik GmbH & Co.

Decision Date2019-09-03

Product CodeDWP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Geomed Vascular Dilators is the device name listed in this FDA 510(k) record. The listed applicant is Geomed Medizin-Technik GmbH & Co.. It received FDA 510(k) clearance on 2019-09-03 under 510(k) number K183438. 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 Geomed Vascular Dilators?

Geomed Vascular Dilators is a medical device that received FDA 510(k) clearance on 2019-09-03. The listed applicant is Geomed Medizin-Technik GmbH & Co.. The 510(k) number is K183438.

When did Geomed Vascular Dilators receive FDA 510(k) clearance?

Geomed Vascular Dilators received FDA 510(k) clearance on 2019-09-03, under 510(k) number K183438.

Who is the listed applicant for Geomed Vascular Dilators?

The FDA 510(k) record lists Geomed Medizin-Technik GmbH & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Geomed Vascular Dilators?

The FDA product code for Geomed Vascular Dilators is DWP.

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.

K220981SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeFehling Surgical Instruments, Inc.K163524Vessel DilatorFetzer Medical GmbH & Co. KG

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.