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Sterile Dilator

by Galt Medical Corp.

510(k) K192195

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192195↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK192195 Date26 Sep 2019ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
DRE
Device class
Class II
Regulation
21 CFR Part 870.1310
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sterile Dilator is a Dilator, Vessel, for Percutaneous Catheterization, designed to facilitate the insertion and dilation of vascular access sites. It is intended for use in percutaneous procedures to prepare vessels for catheter placement, ensuring smooth passage and reducing trauma during insertion.

This device is supplied sterile and is classified as a Class II medical device under FDA regulations (21 CFR 870.1310). It is intended for single-use applications in cardiovascular settings and must be handled in accordance with sterile technique. The Sterile Dilator is authorized under FDA 510(k) clearance (K192195) and meets MDR requirements. Sizes and reference codes are specified in the product’s regulatory submissions.

Other devices from Galt Medical Corp.

See all devices from Galt Medical Corp. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Sterile Dilator primarily used for in clinical settings?

    The Sterile Dilator is designed to facilitate the insertion and dilation of vascular access sites during percutaneous procedures. It prepares vessels for catheter placement by ensuring smooth passage and minimizing trauma during insertion, which is particularly useful in cardiovascular settings.

  • Is the Sterile Dilator intended for single-use or repeated use?

    The Sterile Dilator is explicitly intended for single-use applications only. It is supplied sterile and must be handled using sterile technique, so reuse is not recommended or supported by the manufacturer.

  • How many sizes or models of the Sterile Dilator are available, and how can I identify them?

    The Sterile Dilator comes in multiple sizes, each associated with a unique reference code listed in the manufacturer’s regulatory submissions. While the exact dimensions or specific measurements aren’t detailed here, the product’s regulatory filings (e.g., FDA 510(k) K192195) include these codes for traceability. Contact Galt Medical Corp. for a full list of available sizes and their corresponding reference numbers.

  • What storage or handling precautions should be taken with the Sterile Dilator?

    Since the Sterile Dilator is supplied sterile, it must be stored in its original packaging until use to maintain sterility. The packaging should remain intact and unopened until immediately before the procedure. After opening, it should be used promptly and disposed of according to single-use medical device protocols.

  • What regulatory pathways does the Sterile Dilator follow, and how does that affect its use?

    The Sterile Dilator is authorized under FDA 510(k) clearance (K192195) and meets MDR (Medical Device Regulation) requirements, indicating it has undergone regulatory review for safety and performance. This clearance confirms its compliance with U.S. and EU standards for Class II devices, ensuring it meets established benchmarks for vascular dilation tools in percutaneous procedures. Clinicians can rely on its regulatory status as evidence of its intended use and safety.