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)

14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT

K-Number: K991431 · 1999-05-26

ApplicantArrow Intl., Inc.
Decision Date1999-05-26
Product CodeMPB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 1999-05-26 under 510(k) number K991431. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT?

14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT is a medical device that received FDA 510(k) clearance on 1999-05-26. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K991431.

When did 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT receive FDA 510(k) clearance?

14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT received FDA 510(k) clearance on 1999-05-26, under 510(k) number K991431.

Who is the listed applicant for 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT?

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

What is the FDA product code for 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT?

The FDA product code for 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT is MPB.

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 Arrow Intl., 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.

K100635ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504K093050ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520K071491ARROW INTERNATIONAL, INC., SURGICAL DRAPESK071998ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENTK071111NON-ABSORBABLE SILK SUTUREK060309AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES

View all 110 devices →

Related Devices (Code: MPB)

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.

K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc.K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International CorporationK192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp)K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLCK163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated

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.

↑