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Arstasis Dilator Adapter

by Arstasis, Inc. 510(k)

Active United States

510(k) K103421

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103421 Date24 May 2011ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

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, 1 Oct 2026

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

The Arstasis Dilator Adapter is a Dilator, Vessel, For Percutaneous Catheterization, designed as a sterile, single-use hollow polyethylene component. It serves as an intermediary adapter to bridge the size difference between .018-inch guidewires and larger .035-inch or .038-inch compatible vessel dilators, facilitating compatibility across catheterization procedures. The device is engineered to accommodate dilators up to 23 cm in length, ensuring seamless integration during vascular interventions.

This adapter is supplied as a sterile, single-use device intended for use in percutaneous catheterization procedures within the cardiovascular specialty. It is classified as a Class II medical device under FDA regulation number 870.1310 and holds FDA 510(k) clearance (K103421) through the Traditional 510(k) pathway. The device is non-reusable and must be stored under conditions that maintain sterility until use. No MRI safety information is specified, and its dimensions are standardized to the referenced guidewire and dilator sizes.

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Questions

AI-generated answers, 1 Oct 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 Arstasis Dilator Adapter used for?

    The Arstasis Dilator Adapter is designed as a sterile, single-use hollow polyethylene component that acts as an intermediary between .018-inch guidewires and larger .035-inch or .038-inch compatible vessel dilators. Its purpose is to facilitate compatibility during percutaneous catheterization procedures in the cardiovascular specialty, ensuring seamless integration of dilators up to 23 cm in length.

  • How is the Arstasis Dilator Adapter supplied and what are its sterility and reuse requirements?

    The adapter is supplied as a sterile, single-use device. It must remain sterile until use and is explicitly non-reusable. This ensures patient safety and compliance with medical device standards, as reuse could compromise sterility and integrity.

  • What sizes and models of dilators does the Arstasis Dilator Adapter accommodate?

    The adapter is engineered to accommodate dilators up to 23 cm in length. It bridges the size difference between .018-inch guidewires and larger .035-inch or .038-inch compatible vessel dilators, ensuring compatibility across a range of catheterization procedures.

  • How should the Arstasis Dilator Adapter be stored to maintain sterility?

    The adapter must be stored under conditions that preserve sterility until use. This typically involves keeping it in its original packaging, away from moisture, dust, and extreme temperatures, to prevent contamination or damage.

  • Is there any MRI safety information provided for the Arstasis Dilator Adapter?

    No MRI safety information is specified for the Arstasis Dilator Adapter. If MRI compatibility is required for a procedure, additional precautions or alternative devices should be considered.