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FDA 510(k)

MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING

K-Number: K131517 · 2013-08-02

ApplicantMedrad, Inc. / Bayer Medical Care, Inc.
Decision Date2013-08-02
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc. / Bayer Medical Care, Inc.. It received FDA 510(k) clearance on 2013-08-02 under 510(k) number K131517. 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 MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING?

MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING is a medical device that received FDA 510(k) clearance on 2013-08-02. The listed applicant is Medrad, Inc. / Bayer Medical Care, Inc.. The 510(k) number is K131517.

When did MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING receive FDA 510(k) clearance?

MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING received FDA 510(k) clearance on 2013-08-02, under 510(k) number K131517.

Who is the listed applicant for MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING?

The FDA 510(k) record lists Medrad, Inc. / Bayer Medical Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING?

The FDA product code for MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING is FPK.

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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.

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.K022431MEDRAD 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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