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FDA 510(k)

FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)

K-Number: K001107 · 2000-06-23

ApplicantFresenius Medical Care North America
Decision Date2000-06-23
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) 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 2000-06-23 under 510(k) number K001107. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)?

FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) is a medical device that received FDA 510(k) clearance on 2000-06-23. The listed applicant is Fresenius Medical Care North America. The 510(k) number is K001107.

When did FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) receive FDA 510(k) clearance?

FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) received FDA 510(k) clearance on 2000-06-23, under 510(k) number K001107.

Who is the listed applicant for FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)?

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 COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)?

The FDA product code for FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) is FJK.

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Other records listing Fresenius Medical Care North America as applicant

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Related Devices (Code: FJK)

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.

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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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