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FDA 510(k)

THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN

K-Number: K131023 · 2013-10-11

ApplicantMedical Products, LLC
Decision Date2013-10-11
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN is the device name listed in this FDA 510(k) record. The listed applicant is Medical Products, LLC. It received FDA 510(k) clearance on 2013-10-11 under 510(k) number K131023. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN?

THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN is a medical device that received FDA 510(k) clearance on 2013-10-11. The listed applicant is Medical Products, LLC. The 510(k) number is K131023.

When did THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN receive FDA 510(k) clearance?

THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN received FDA 510(k) clearance on 2013-10-11, under 510(k) number K131023.

Who is the listed applicant for THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN?

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

What is the FDA product code for THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN?

The FDA product code for THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN is NFB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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