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FDA 510(k)

MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION

K-Number: K053286 · 2005-12-22

ApplicantNxstage Medical, Inc.
Decision Date2005-12-22
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION 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 2005-12-22 under 510(k) number K053286. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION?

MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION is a medical device that received FDA 510(k) clearance on 2005-12-22. The listed applicant is Nxstage Medical, Inc.. The 510(k) number is K053286.

When did MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION receive FDA 510(k) clearance?

MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION received FDA 510(k) clearance on 2005-12-22, under 510(k) number K053286.

Who is the listed applicant for MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION?

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 MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION?

The FDA product code for MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION is KPO.

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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: KPO)

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.

K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, IncoporatedK253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius 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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