Arrow Endurance Extended Dwell Peripheral Catheter System (4 models)— 510(k) K242281
Substantially EquivalentArrow International, LLC (A subsidiary of Teleflex, Inc.)
FDA 510(k) clearance K242281 for Arrow Endurance Extended Dwell Peripheral Catheter System (4 models), Substantially Equivalent on 2024-12-20. Applicant: Arrow International, LLC (A subsidiary of Teleflex, Inc.). Device class: 2.
Clearance details
- Device name as filed
- Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)
- Applicant
- Arrow International, LLC (A 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
- Morrisville, NC, US
Recent devices under product code FOZ
view allMore clearances from Arrow International, LLC (A subsidiary of Teleflex, Inc.)
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.