FDA 510(k)

SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS

K-Number: K011187 · 2001-06-19

Decision Date2001-06-19

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Medivations, Inc.. It received FDA 510(k) clearance on 2001-06-19 under 510(k) number K011187. 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 SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS?

SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS is a medical device that received FDA 510(k) clearance on 2001-06-19. The listed applicant is Sterling Medivations, Inc.. The 510(k) number is K011187.

When did SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS receive FDA 510(k) clearance?

SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS received FDA 510(k) clearance on 2001-06-19, under 510(k) number K011187.

Who is the listed applicant for SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS?

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

What is the FDA product code for SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS?

The FDA product code for SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS is FPA.

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Other records listing Sterling Medivations, Inc. as applicant

K021530SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN K021487SIMPLICITY EASY ACCESS P INFUSION SET K021296SIMPLICITY QD EASY P INFUSION SET K021216SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS K021005SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE K020912SIMPLICITY EASY SOFT INFUSION SET

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Related Devices (Code: FPA)

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC K261530iiSure Infusion SetDeka Research and Development K252543AMSafe 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 Medical K250325BD 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.