Skip to content

Access. to Interavacular Admin. Set

by Tanner Corp.

510(k) K842657

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 NumberK842657 Date17 Aug 1984ClearedStatusActive

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  • Withdrawn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
FPA
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
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.

This device is an access to interavacular administration set, used for delivering fluids or medications into the vascular system. It is designed to establish and maintain access for intravenous therapy.

It is supplied as a sterile, single-use device intended for use in general hospital settings. The device has received FDA 510(k) clearance (K842657) and is classified under product code FPA.

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 ACCESS. TO INTERAVACULAR ADMIN. SET used for?

    The ACCESS. TO INTERAVACULAR ADMIN. SET is used to deliver fluids or medications into the vascular system by establishing and maintaining access for intravenous therapy in general hospital settings.

  • How is the ACCESS. TO INTERAVACULAR ADMIN. SET supplied and is it reusable?

    The device is supplied as a sterile, single-use device, meaning it is intended for one-time use only and should not be reprocessed or reused after initial use to ensure patient safety and sterility.

  • What regulatory clearance does the ACCESS. TO INTERAVACULAR ADMIN. SET have?

    The device has received FDA 510(k) clearance under submission number K842657 and is classified under product code FPA, indicating it was found substantially equivalent to a legally marketed predicate device.