DORA Disposable A.V. Fistula Needle Sets
K-Number: K213015 · 2022-04-08
Device Summary
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 2022-04-08. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K213015.
When did DORA Disposable A.V. Fistula Needle Sets receive FDA 510(k) clearance?
DORA Disposable A.V. Fistula Needle Sets received FDA 510(k) clearance on 2022-04-08, under 510(k) number K213015.
Who is the listed applicant for DORA Disposable A.V. Fistula Needle Sets?
The FDA 510(k) record lists Bain Medical Equipment (Guangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
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.
Other records listing Bain Medical Equipment (Guangzhou) Co., Ltd. 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.
Related Devices (Code: FIE)
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.
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.