FDA 510(k)

K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR

K-Number: K102994 · 2010-11-03

Decision Date2010-11-03

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories, Inc.. It received FDA 510(k) clearance on 2010-11-03 under 510(k) number K102994. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR?

K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR is a medical device that received FDA 510(k) clearance on 2010-11-03. The listed applicant is Kawasumi Laboratories, Inc.. The 510(k) number is K102994.

When did K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR receive FDA 510(k) clearance?

K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR received FDA 510(k) clearance on 2010-11-03, under 510(k) number K102994.

Who is the listed applicant for K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR?

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

What is the FDA product code for K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR?

The FDA product code for K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR is FMI.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kawasumi Laboratories, Inc. as applicant

K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)K190233K-Shield Advantage Port Access Infusion Set (PAIS)K172957Kawasumi Laboratories Blood Drawing Kit (BDK) System K123344K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)K100720K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING K073257KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR

View all 11 devices →

Related Devices (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

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.