DORA Disposable A.V. Fistula Needle Sets— 510(k) K163025
Substantially EquivalentBain Medical Equipment (Guangzhou) Co., Ltd.
FDA 510(k) clearance K163025 for DORA Disposable A.V. Fistula Needle Sets, Substantially Equivalent on 2017-07-20. Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Bain Medical Equipment (Guangzhou) Co., Ltd.
- Product code
- Code FIE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code FIE
view all- K253469 — Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM) +5 more
- K251877 — JMS CAVEO A.V. Fistula Needle Set
- K213015 — DORA Disposable A.V. Fistula Needle Sets
- K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
- K151017 — JMS Harmony A.V. Fistula Needle Set
More clearances from Bain Medical Equipment (Guangzhou) Co., Ltd.
view allAdverse events under product code FIE
product code FIE- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.