APLAN A.V. FISTULA NEEDLE SET— 510(k) K112734
Substantially EquivalentAplan Well Enterprise Co., Ltd.
FDA 510(k) clearance K112734 for APLAN A.V. FISTULA NEEDLE SET, Substantially Equivalent on 2012-04-24. Applicant: Aplan Well Enterprise Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Aplan Well Enterprise 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
- Hsin Chu City, TW
Recent devices under product code FIE
view all- K253469 — Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM) +5 more
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- K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
- K163025 — DORA Disposable A.V. Fistula Needle Sets
Adverse 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.