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FDA 510(k)

SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT

K-Number: K931377 · 1994-03-07

ApplicantMcgaw, Inc.
Decision Date1994-03-07
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Mcgaw, Inc.. It received FDA 510(k) clearance on 1994-03-07 under 510(k) number K931377. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT?

SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Mcgaw, Inc.. The 510(k) number is K931377.

When did SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT receive FDA 510(k) clearance?

SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT received FDA 510(k) clearance on 1994-03-07, under 510(k) number K931377.

Who is the listed applicant for SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT?

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

What is the FDA product code for SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT?

The FDA product code for SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT is FPA.

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Other records listing Mcgaw, 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.

K972678MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETSK955595SAFELINE MULTIDOSE VIAL ADAPTERK955594SAFELINE I.V. BAG ACCESS DEVICEK941244SAFELINE SYSTEM TURN LOCK CANNULAK932165INTRAVASCULAR ADMINISTRATION SETK932856IRRIGATION ACCESS CAP

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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