FDA 510(k)

SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)

K-Number: K072894 · 2007-11-06

Decision Date2007-11-06

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Europe N.V.. It received FDA 510(k) clearance on 2007-11-06 under 510(k) number K072894. 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 SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)?

SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) is a medical device that received FDA 510(k) clearance on 2007-11-06. The listed applicant is Terumo Europe N.V.. The 510(k) number is K072894.

When did SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) receive FDA 510(k) clearance?

SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) received FDA 510(k) clearance on 2007-11-06, under 510(k) number K072894.

Who is the listed applicant for SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)?

The FDA 510(k) record lists Terumo Europe N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD)?

The FDA product code for SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) is FPA.

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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.