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FDA 510(k)

RENAGUARD DIALYSATE FILTER

K-Number: K945136 · 1995-02-28

ApplicantMinntech Corp.
Decision Date1995-02-28
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENAGUARD DIALYSATE FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Minntech Corp.. It received FDA 510(k) clearance on 1995-02-28 under 510(k) number K945136. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENAGUARD DIALYSATE FILTER?

RENAGUARD DIALYSATE FILTER is a medical device that received FDA 510(k) clearance on 1995-02-28. The listed applicant is Minntech Corp.. The 510(k) number is K945136.

When did RENAGUARD DIALYSATE FILTER receive FDA 510(k) clearance?

RENAGUARD DIALYSATE FILTER received FDA 510(k) clearance on 1995-02-28, under 510(k) number K945136.

Who is the listed applicant for RENAGUARD DIALYSATE FILTER?

The FDA 510(k) record lists Minntech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENAGUARD DIALYSATE FILTER?

The FDA product code for RENAGUARD DIALYSATE FILTER is FIP.

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Other records listing Minntech Corp. as applicant

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Related Devices (Code: FIP)

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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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