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FDA 510(k)

POLYFIN EXTENSION SET, MODELS 126 AND 128

K-Number: K965208 · 1997-02-26

ApplicantMedtronic Minimed
Decision Date1997-02-26
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLYFIN EXTENSION SET, MODELS 126 AND 128 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Minimed. It received FDA 510(k) clearance on 1997-02-26 under 510(k) number K965208. 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 POLYFIN EXTENSION SET, MODELS 126 AND 128?

POLYFIN EXTENSION SET, MODELS 126 AND 128 is a medical device that received FDA 510(k) clearance on 1997-02-26. The listed applicant is Medtronic Minimed. The 510(k) number is K965208.

When did POLYFIN EXTENSION SET, MODELS 126 AND 128 receive FDA 510(k) clearance?

POLYFIN EXTENSION SET, MODELS 126 AND 128 received FDA 510(k) clearance on 1997-02-26, under 510(k) number K965208.

Who is the listed applicant for POLYFIN EXTENSION SET, MODELS 126 AND 128?

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 EXTENSION SET, MODELS 126 AND 128?

The FDA product code for POLYFIN EXTENSION SET, MODELS 126 AND 128 is FPK.

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Other records listing Medtronic Minimed as applicant

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K261962SmartGuard Technology; Predictive Low Glucose TechnologyK253701SmartGuard Technology; Predictive Low Glucose TechnologyK253512MiniMed Go AppK242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))K241622Extended Reservoir; MiniMed ReservoirK160860MiniMed Quick-serter

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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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