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Pheripherally Inserted Venous Catheter-Y Site

by Pharmacia Deltec, Inc.

510(k) K932433

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)SESK Substantially Equivalent — Kit · Traditional NumberK932433 Date2 May 1994ClearedStatusActive

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  • Withdrawn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
LJS
Device Class
Class II
Regulation
21 CFR Part 880.5970
Advisory Committee
General Hospital
FDA Decision
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 21 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 Peripherally Inserted Venous Catheter-Y Site is an intravascular, therapeutic catheter intended for long-term use exceeding 30 days. It is designed to provide venous access for the administration of fluids or medications.

This device is subject to FDA 510(k) authorization. Specific details regarding its sterility, single-use status, or MRI compatibility are not provided in the available documentation.

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Questions

AI-generated answers, 21 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 intended use of the Peripherally Inserted Venous Catheter-Y Site?

    This device is an intravascular, therapeutic catheter designed to provide venous access for the administration of fluids or medications to a patient.

  • Is this catheter suitable for long-term treatment?

    Yes, the device is specifically intended for long-term use, defined as a duration exceeding 30 days.

  • What is the regulatory status of this device?

    The Peripherally Inserted Venous Catheter-Y Site is subject to FDA 510(k) authorization, which indicates it has been cleared for market distribution under the specified regulatory pathway.