FDA 510(k)

A.V. FISTULA BLUNT NEEDLE SET

K-Number: K082882 · 2009-01-21

Decision Date2009-01-21

Product CodeFIE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

A.V. FISTULA BLUNT NEEDLE SET 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 2009-01-21 under 510(k) number K082882. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A.V. FISTULA BLUNT NEEDLE SET?

A.V. FISTULA BLUNT NEEDLE SET is a medical device that received FDA 510(k) clearance on 2009-01-21. The listed applicant is Jms North America Corp.. The 510(k) number is K082882.

When did A.V. FISTULA BLUNT NEEDLE SET receive FDA 510(k) clearance?

A.V. FISTULA BLUNT NEEDLE SET received FDA 510(k) clearance on 2009-01-21, under 510(k) number K082882.

Who is the listed applicant for A.V. FISTULA BLUNT NEEDLE SET?

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 A.V. FISTULA BLUNT NEEDLE SET?

The FDA product code for A.V. FISTULA BLUNT NEEDLE SET is FIE.

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 Jms North America Corp. as applicant

K093637JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 K070234JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS K070143JMS PLANECTA STOPCOCK K051814JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET K032975JMS BLOOD TUBING SETS K032977JMS BYPASS TUBE

View all 10 devices →

Related Devices (Code: FIE)

K253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)Mozarc Medical Us, LLC K251877JMS CAVEO A.V. Fistula Needle SetJMS North America Corporation K213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)Dimesol, Inc.K163025DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K112734APLAN A.V. FISTULA NEEDLE SETAplan Well Enterprise Co., 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.