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FDA 510(k)

RENAFLO II HF 2000 HEMOFILTER

K-Number: K000028 · 2000-04-04

ApplicantMinntech Corp.
Decision Date2000-04-04
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RENAFLO II HF 2000 HEMOFILTER is the device name listed in this FDA 510(k) record. The listed applicant is Minntech Corp.. It received FDA 510(k) clearance on 2000-04-04 under 510(k) number K000028. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENAFLO II HF 2000 HEMOFILTER?

RENAFLO II HF 2000 HEMOFILTER is a medical device that received FDA 510(k) clearance on 2000-04-04. The listed applicant is Minntech Corp.. The 510(k) number is K000028.

When did RENAFLO II HF 2000 HEMOFILTER receive FDA 510(k) clearance?

RENAFLO II HF 2000 HEMOFILTER received FDA 510(k) clearance on 2000-04-04, under 510(k) number K000028.

Who is the listed applicant for RENAFLO II HF 2000 HEMOFILTER?

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 RENAFLO II HF 2000 HEMOFILTER?

The FDA product code for RENAFLO II HF 2000 HEMOFILTER is KDI.

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Other records listing Minntech Corp. as applicant

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.

K120306RAPICIDE OPA-28K092387MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEMK071298HF JUNIOR HEMOFILTERK050952HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATORK033505RENACLEAN SH DIALYZER CLEANING SYSTEMK014016ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

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Related Devices (Code: KDI)

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.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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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