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)

DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT

K-Number: K090528 · 2009-05-28

ApplicantC.R. Bard, Inc.
Decision Date2009-05-28
Product CodeMSD
Advisory CommitteeGU
DecisionUnknown

Device Summary

DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2009-05-28 under 510(k) number K090528. 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 DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT?

DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT is a medical device that received FDA 510(k) clearance on 2009-05-28. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K090528.

When did DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT receive FDA 510(k) clearance?

DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT received FDA 510(k) clearance on 2009-05-28, under 510(k) number K090528.

Who is the listed applicant for DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT?

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

What is the FDA product code for DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT?

The FDA product code for DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR 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 C.R. Bard, 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.

K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitK252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)K251864Rubber Utility CatheterK251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,

View all 616 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.

↑