Arrow Endurance Extended Dwell Peripheral Catheter System— 510(k) K163513
Substantially EquivalentArrow International, Inc. (Subsidiary of Teleflex, Inc.)
FDA 510(k) clearance K163513 for Arrow Endurance Extended Dwell Peripheral Catheter System, Substantially Equivalent on 2017-02-24. Applicant: Arrow International, Inc. (Subsidiary of Teleflex, Inc.). Device class: 2.
Clearance details
- Applicant
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Reading, PA, US
Recent devices under product code FOZ
view allMore clearances from Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
view all- K180395 — EZ-IO Intraosseous Vascular Access System
- K161313 — ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology
- K160018 — Arrow Quickflash Arterial Catheterization Device
- K153487 — CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
- K153423 — CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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 →
Recalls naming K163513
K-number listed on FDA's recall record- Z-1826-2023 — ARROW Endurance Extended Dwell Peripheral Catheter System
- Z-0837-2020 — Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163513.
Data sourced from openFDA. This site is unofficial and independent of the FDA.