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)

DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT

K-Number: K110936 · 2011-06-10

ApplicantAngioDynamics, Inc.
Decision Date2011-06-10
Product CodeMSD
Advisory CommitteeGU
DecisionUnknown

Device Summary

DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2011-06-10 under 510(k) number K110936. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT?

DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 2011-06-10. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K110936.

When did DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT receive FDA 510(k) clearance?

DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT received FDA 510(k) clearance on 2011-06-10, under 510(k) number K110936.

Who is the listed applicant for DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT?

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

What is the FDA product code for DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT?

The FDA product code for DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT is MSD.

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 AngioDynamics, 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.

K252509AlphaVac Multipurpose Mechanical Aspiration System F1885K253106AngioVac CannulaK242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)K240397AlphaVac MMA F1885 System (H787253020)K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsK223581Solero Microwave Tissue Ablation (MTA) System and Accessories

View all 82 devices →

Related Devices (Code: MSD)

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.

K241581Hemodialysis CatheterHaolang Medical USA CorporationK210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, 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.

↑