FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
DORA Disposable A.V. Fistula Needle Sets
K Number: K163025
·
Decision Jul 20, 2017
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
7
Review Days
262
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Basic Information
- Device Name
- DORA Disposable A.V. Fistula Needle Sets
- K Number
- K163025
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bain Medical Equipment (Guangzhou) Co., Ltd.
- Date Received
- October 31, 2016
- Decision Date
- July 20, 2017
- Product Code
- FIE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FIE | Needle, Fistula | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIE), ordered by most recent decision date.
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DORA Disposable A.V. Fistula Needle Sets
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Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
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ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
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JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
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·Gastroenterology, Urology
Other Clearances by Bain Medical Equipment (Guangzhou) Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124) | May 15, 2026 | Substantially Equivalent |
| K240164 | NovaLine SP-C35 Transducer Protector (956007) | Jun 28, 2024 | Substantially Equivalent |
| K213015 | DORA Disposable A.V. Fistula Needle Sets | Apr 8, 2022 | Substantially Equivalent |
| K201866 | NovaLine Tubing Sets for Hemodialysis | Mar 10, 2021 | Substantially Equivalent |
| K203524 | Surgical Masks | Feb 25, 2021 | Substantially Equivalent |
| K161582 | DORA Tubing Sets for Hemodialysis | Jun 16, 2017 | Substantially Equivalent |