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)

JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS

K-Number: K070234 · 2007-05-22

ApplicantJms North America Corp.
Decision Date2007-05-22
Product CodeMPB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS is the device name listed in this FDA 510(k) record. The listed applicant is Jms North America Corp.. It received FDA 510(k) clearance on 2007-05-22 under 510(k) number K070234. 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 JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS?

JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS is a medical device that received FDA 510(k) clearance on 2007-05-22. The listed applicant is Jms North America Corp.. The 510(k) number is K070234.

When did JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS receive FDA 510(k) clearance?

JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS received FDA 510(k) clearance on 2007-05-22, under 510(k) number K070234.

Who is the listed applicant for JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS?

The FDA 510(k) record lists Jms North America Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS?

The FDA product code for JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS 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 Jms North America Corp. 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.

K093637JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300K082882A.V. FISTULA BLUNT NEEDLE SETK070143JMS PLANECTA STOPCOCKK051814JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SETK032975JMS BLOOD TUBING SETSK032977JMS BYPASS TUBE

View all 10 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.

↑