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FDA 510(k)

NXSTAGE PUREFLOW SL

K-Number: K080919 · 2008-10-15

ApplicantNxstage Medical, Inc.
Decision Date2008-10-15
Product CodeFKR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NXSTAGE PUREFLOW SL is the device name listed in this FDA 510(k) record. The listed applicant is Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2008-10-15 under 510(k) number K080919. The device is classified under product code FKR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NXSTAGE PUREFLOW SL?

NXSTAGE PUREFLOW SL is a medical device that received FDA 510(k) clearance on 2008-10-15. The listed applicant is Nxstage Medical, Inc.. The 510(k) number is K080919.

When did NXSTAGE PUREFLOW SL receive FDA 510(k) clearance?

NXSTAGE PUREFLOW SL received FDA 510(k) clearance on 2008-10-15, under 510(k) number K080919.

Who is the listed applicant for NXSTAGE PUREFLOW SL?

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

What is the FDA product code for NXSTAGE PUREFLOW SL?

The FDA product code for NXSTAGE PUREFLOW SL is FKR.

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Other records listing Nxstage Medical, Inc. 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.

K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)K233213NxStage PureFlow SolutionK230632VersiHD with GuideMe softwareK183158NxStage Cartridge Express with SpeedswapK181991NxStage Connected Health SystemK171331NxStage System One

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Related Devices (Code: FKR)

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.

K111174NXSTAGE PUREFLOW SLNxstage Medical, Inc.K060296NXSTAGE DIALYSATE PREPARATION MODULENxstage Medical, Inc.K043436NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269Nxstage Medical, Inc.K850435SARTORIUS AQUASART SM 40035 - DIALYSATE SYSSartorius Filters, Inc.K850756AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTSTravenol Laboratories, S.A.K810605CHEMATIC BICARBONATE DIALYSATE SYSTEMTrimedyne, Inc.

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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