Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811

K-Number: K100334 · 2010-04-22

ApplicantB. Braun Avitum AG
Decision Date2010-04-22
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun Avitum AG. It received FDA 510(k) clearance on 2010-04-22 under 510(k) number K100334. 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 DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811?

DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 is a medical device that received FDA 510(k) clearance on 2010-04-22. The listed applicant is B. Braun Avitum AG. The 510(k) number is K100334.

When did DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 receive FDA 510(k) clearance?

DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 received FDA 510(k) clearance on 2010-04-22, under 510(k) number K100334.

Who is the listed applicant for DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811?

The FDA 510(k) record lists B. Braun Avitum AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811?

The FDA product code for DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 is KDI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing B. Braun Avitum AG 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.

K170574Diacap Pro DialyzerK143482xevonta dialyzerK102194SOLCART BK083460DIALOG WITH ADIMEA OPTION

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.

↑