Geomed Vascular Dilators

FDA 510(k) K183438 · Geomed Medizin-Technik GmbH & Co.

Substantially Equivalent

510(k) numberK183438

Submission

Device name
Geomed Vascular Dilators
Applicant
Geomed Medizin-Technik GmbH & Co.
Tuttlingen, DE
Received
December 12, 2018
Decision date
September 3, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DWP – Dilator, Vessel, Surgical
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4475
Specialty
Cardiovascular

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K130896Vascular Probe, Vascular Probe EsDWP · Traditional Synovis Life Technologies, Inc.04/24/2013SE
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K960312Rdi Cardiac Insulation PadDWP · Traditional R D Intl.04/19/1996SE
K912548Lemaitre-Bookwalter Vessel DevicesDWP · Traditional Vascutech, Inc.09/18/1991SE
K911475Laparoscopic Vessel ArticulatorDWP · Traditional United States Endoscopy Group, Inc.07/02/1991SE
K910682Robicsek Probe/RetractorDWP · Traditional Bio-Vascular, Inc.05/08/1991SE
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Questions and answers

When was Geomed Vascular Dilators cleared by the FDA?

Geomed Vascular Dilators (K183438) received a 510(k) decision of Substantially Equivalent on September 3, 2019, 265 days after the submission was received.

What is the product code of K183438?

The FDA product code is DWP – Dilator, Vessel, Surgical, a Class II (moderate risk) device regulated under 21 CFR 870.4475.