LIFESHIELD EXTENSION SET— 510(k) K941214

Clearance details

Applicant

Abbott Mfg., Inc.

Product code

Code FPK

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

1994-03-10

Decision date

1994-10-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Abbott Park, IL, US

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• K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725)2004-07-16

• K981457 — ALBP1998-05-27
• K981232 — CA1998-05-18
• K981231 — CO21998-05-12
• K965230 — ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP1997-07-03
• K971293 — LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE1997-06-27

• Z-1016-2017 — Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.Class II·Terminated·Hospira Inc.·20130219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K941214.