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Pharmacia Deltec Bag Spike Set

by Pharmacia Deltec, Inc.

510(k) K873876

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 NumberK873876 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  • Withdrawn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, 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 Pharmacia Deltec Bag Spike Set is an intravenous administration set designed to pierce and access the contents of flexible IV bags. It facilitates the connection between a bag of intravenous fluid and the patient's vascular access, allowing for controlled fluid delivery.

The device is supplied as a single-use, sterile unit intended for general hospital settings. It is regulated under the FDA product code FPA for intravascular administration sets and was reviewed under the General Hospital advisory committee panel.

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