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FDA 510(k)

PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000

K-Number: K923727 · 1994-07-29

ApplicantMinntech Corp.
Decision Date1994-07-29
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Minntech Corp.. It received FDA 510(k) clearance on 1994-07-29 under 510(k) number K923727. 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 PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000?

PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000 is a medical device that received FDA 510(k) clearance on 1994-07-29. The listed applicant is Minntech Corp.. The 510(k) number is K923727.

When did PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000 receive FDA 510(k) clearance?

PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000 received FDA 510(k) clearance on 1994-07-29, under 510(k) number K923727.

Who is the listed applicant for PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000?

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 PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000?

The FDA product code for PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000 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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