DORA Disposable A.V. Fistula Needle Sets
K-Number: K163025 · 2017-07-20
Decision Date2017-07-20
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
DORA Disposable A.V. Fistula Needle Sets is a medical device manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2017-07-20 under approval number K163025. 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 DORA Disposable A.V. Fistula Needle Sets?
DORA Disposable A.V. Fistula Needle Sets is a medical device that received FDA 510(k) clearance on 2017-07-20. It is manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K163025.
When was DORA Disposable A.V. Fistula Needle Sets approved by the FDA?
DORA Disposable A.V. Fistula Needle Sets received FDA 510(k) clearance on 2017-07-20, under approval number K163025.
What company makes DORA Disposable A.V. Fistula Needle Sets?
DORA Disposable A.V. Fistula Needle Sets is manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd..
What is the FDA product code for DORA Disposable A.V. Fistula Needle Sets?
The FDA product code for DORA Disposable A.V. Fistula Needle Sets is FIE.
Related Clinical Trials
Other Devices by Bain Medical Equipment (Guangzhou) Co., Ltd.
Related Devices (Code: FIE)
K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)Dimesol, Inc.
K213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.
K251877JMS CAVEO A.V. Fistula Needle SetJMS North America Corporation
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.