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Percutaneous Introducer Kit

by Accu-Line

510(k) K831636

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK831636 Date24 Aug 1983ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Percutaneous Introducer Kit is a Class II medical device classified under product code DQY, designed as a percutaneous introducer sheath system. It facilitates vascular access by providing a pathway for catheter or guidewire insertion into veins or arteries through the skin, supporting procedures such as central venous catheterization or interventional radiology.

This kit is intended for single-use and is supplied sterile, requiring no additional preparation before use. It is regulated under FDA 510(k) clearance (K831636) and falls under the Cardiovascular advisory committee classification. Storage should adhere to manufacturer guidelines to maintain sterility and functionality, with no specific MRI safety considerations noted in the available data.

Other devices from Accu-Line

Questions

AI-generated answers, 19 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 purpose of the Percutaneous Introducer Kit?

    The Percutaneous Introducer Kit is designed to facilitate vascular access by providing a pathway for catheter or guidewire insertion into veins or arteries through the skin, supporting procedures such as central venous catheterization or interventional radiology.

  • Is the Percutaneous Introducer Kit reusable or single-use?

    The kit is intended for single-use only and is supplied sterile, requiring no additional preparation before use.

  • What regulatory status does the Percutaneous Introducer Kit have?

    The Percutaneous Introducer Kit is regulated under FDA 510(k) clearance with K number K831636 and is classified under product code DQY.

  • Are there any specific storage requirements for the Percutaneous Introducer Kit?

    Storage should adhere to manufacturer guidelines to maintain sterility and functionality, with no specific MRI safety considerations noted in the available data.