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FDA 510(k)

FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9

K-Number: K010268 · 2001-04-27

ApplicantFresenius Medical Care North America
Decision Date2001-04-27
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care North America. It received FDA 510(k) clearance on 2001-04-27 under 510(k) number K010268. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9?

FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 is a medical device that received FDA 510(k) clearance on 2001-04-27. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K010268.

When did FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 receive FDA 510(k) clearance?

FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 received FDA 510(k) clearance on 2001-04-27, under 510(k) number K010268.

Who is the listed applicant for FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9?

The FDA 510(k) record lists Fresenius Medical Care North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9?

The FDA product code for FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 is KOC.

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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.

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