Arrow Endurance Extended Dwell Peripheral Catheter System— 510(k) K151513
Substantially EquivalentArrow Internation, Inc. (Subsidiary of Teleflex Inc.)
FDA 510(k) clearance K151513 for Arrow Endurance Extended Dwell Peripheral Catheter System, Substantially Equivalent on 2015-07-08. Applicant: Arrow Internation, Inc. (Subsidiary of Teleflex Inc.). Device class: 2.
Clearance details
- Applicant
- Arrow Internation, 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
- Traditional
- Location
- Reading, PA, US
Recent devices under product code FOZ
view allAdverse 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 K151513
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151513.
Data sourced from openFDA. This site is unofficial and independent of the FDA.