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.).
Clearance details
- Applicant
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Product code
- Code FOZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Reading, PA, US
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.