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FDA 510(k)

POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333

K-Number: K964455 · 1997-01-30

ApplicantMedtronic Minimed
Decision Date1997-01-30
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 1997-01-30 under 510(k) number K964455. 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 POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333?

POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333 is a medical device that received FDA 510(k) clearance on 1997-01-30. The listed applicant is Medtronic Minimed. The 510(k) number is K964455.

When did POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333 receive FDA 510(k) clearance?

POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333 received FDA 510(k) clearance on 1997-01-30, under 510(k) number K964455.

Who is the listed applicant for POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333?

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

What is the FDA product code for POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333?

The FDA product code for POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333 is FPA.

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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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