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FDA 510(k)

LIFESHIELD EXTENSION SET

K-Number: K941214 · 1994-10-03

ApplicantAbbott Mfg., Inc.
Decision Date1994-10-03
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LIFESHIELD EXTENSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Mfg., Inc.. It received FDA 510(k) clearance on 1994-10-03 under 510(k) number K941214. The device is classified under product code FPK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFESHIELD EXTENSION SET?

LIFESHIELD EXTENSION SET is a medical device that received FDA 510(k) clearance on 1994-10-03. The listed applicant is Abbott Mfg., Inc.. The 510(k) number is K941214.

When did LIFESHIELD EXTENSION SET receive FDA 510(k) clearance?

LIFESHIELD EXTENSION SET received FDA 510(k) clearance on 1994-10-03, under 510(k) number K941214.

Who is the listed applicant for LIFESHIELD EXTENSION SET?

The FDA 510(k) record lists Abbott Mfg., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFESHIELD EXTENSION SET?

The FDA product code for LIFESHIELD EXTENSION SET is FPK.

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Other records listing Abbott Mfg., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K981457ALBPK981232CAK981231CO2K965230ABBOTT LIFECARE STANDARD TUBING INFUSION PUMPK971293LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVEK953656ABBOTT IMX PROLACTIN(MODIFICATION)

View all 14 devices →

Related Devices (Code: FPK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131517MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGMedrad, Inc. / Bayer Medical Care, Inc.K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESCoeur, Inc.K063239LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526Hospira, Inc.K052431MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1Medtronic MinimedK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)E-Z-Em, Inc.K031808MEDRAD SWABBABLE VALVE TRANSFER SETMedrad, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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