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Access Percutaneous Introducer Set

by Access Devices, Inc.

510(k) K822834

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 NumberK822834 Date1 Nov 1982ClearedStatusActive

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  • Withdrawn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
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 ACCESS PERCUTANEOUS INTRODUCER SET is a percutaneous introducer set used for establishing vascular access. It is classified under the product code DYB and was determined to be substantially equivalent to a predicate device through the FDA 510(k) process.

The device was cleared via the traditional 510(k) pathway, with a decision date of November 1, 1982, and a receipt date of September 21, 1982. It is manufactured by Access Devices, Inc., located in Walker, MI, and is identified by the K-number K822834.

Other devices from Access Devices, Inc.

Questions

AI-generated answers, 24 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 ACCESS PERCUTANEOUS INTRODUCER SET used for?

    The ACCESS PERCUTANEOUS INTRODUCER SET is used for establishing vascular access, allowing clinicians to introduce catheters or other devices into blood vessels percutaneously.

  • Who manufactures the ACCESS PERCUTANEOUS INTRODUCER SET and where are they located?

    The ACCESS PERCUTANEOUS INTRODUCER SET is manufactured by Access Devices, Inc., located at 4221 Richmond Rd., NW, Walker, MI 49534, United States.

  • What regulatory pathway was used to clear the ACCESS PERCUTANEOUS INTRODUCER SET and when was it cleared?

    The ACCESS PERCUTANEOUS INTRODUCER SET was cleared via the traditional FDA 510(k) pathway, with a decision date of November 1, 1982, following receipt of the submission on September 21, 1982.

  • What is the K-number and product code for the ACCESS PERCUTANEOUS INTRODUCER SET?

    The ACCESS PERCUTANEOUS INTRODUCER SET is identified by K-number K822834 and product code DYB, which classifies it under the cardiovascular advisory committee category.