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Model 1330 Extension Set

by Pharmacia Deltec, Inc.

510(k) K873042

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 NumberK873042 Date23 Oct 1987ClearedStatusActive

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  • Withdrawn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, 22 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 Model 1330 Extension Set is a medical device used for intravenous fluid administration. It is designed to connect to infusion systems and facilitate the delivery of fluids to patients.

This extension set is supplied by Pharmacia Deltec, Inc. and is intended for use in general hospital settings. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.

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Questions

AI-generated answers, 22 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 Model 1330 Extension Set used for?

    The Model 1330 Extension Set is a medical device designed for intravenous fluid administration. It connects to infusion systems to facilitate the delivery of fluids to patients in general hospital settings.

  • Is the Model 1330 Extension Set single-use or reusable?

    The device data does not specify whether the Model 1330 Extension Set is single-use or reusable. This information would need to be obtained from the manufacturer's instructions for use or product labeling.

  • What are the regulatory details for the Model 1330 Extension Set?

    The Model 1330 Extension Set received FDA 510(k) clearance with K number K873042 on October 23, 1987. It was determined to be substantially equivalent to predicate devices and is classified under product code FPA for general hospital use.

  • Who manufactures the Model 1330 Extension Set?

    The Model 1330 Extension Set is manufactured by Pharmacia Deltec, Inc., located at 1265 Grey Fox Rd., St. Paul, MN 55112. The contact person listed is Edward Numainville.