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FDA 510(k)

GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS

K-Number: K042938 · 2005-01-06

ApplicantGambro Renal Products
Decision Date2005-01-06
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS is the device name listed in this FDA 510(k) record. The listed applicant is Gambro Renal Products. It received FDA 510(k) clearance on 2005-01-06 under 510(k) number K042938. 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 GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS?

GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS is a medical device that received FDA 510(k) clearance on 2005-01-06. The listed applicant is Gambro Renal Products. The 510(k) number is K042938.

When did GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS receive FDA 510(k) clearance?

GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS received FDA 510(k) clearance on 2005-01-06, under 510(k) number K042938.

Who is the listed applicant for GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS?

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

What is the FDA product code for GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS?

The FDA product code for GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS is KDI.

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Other records listing Gambro Renal Products 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.

K120333PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPYK072908PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYK070414GAMBRO CARTRIDGE BLOOD SETSK063290GAMBRO QUICKSET BLOODLINESK062090PRISMA SYSTEM R03.10AK060195GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE

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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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