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FDA 510(k)

GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET

K-Number: K955497 · 1997-09-25

ApplicantCobe Renal Care, Inc.
Decision Date1997-09-25
Product CodeKDL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Renal Care, Inc.. It received FDA 510(k) clearance on 1997-09-25 under 510(k) number K955497. The device is classified under product code KDL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET?

GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET is a medical device that received FDA 510(k) clearance on 1997-09-25. The listed applicant is Cobe Renal Care, Inc.. The 510(k) number is K955497.

When did GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET receive FDA 510(k) clearance?

GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET received FDA 510(k) clearance on 1997-09-25, under 510(k) number K955497.

Who is the listed applicant for GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET?

The FDA 510(k) record lists Cobe Renal Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET?

The FDA product code for GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET is KDL.

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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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