ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology— 510(k) K161313
Substantially EquivalentArrow International, Inc. (Subsidiary of Teleflex, Inc.)
FDA 510(k) clearance K161313 for ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology, Substantially Equivalent on 2016-08-24. Applicant: Arrow International, Inc. (Subsidiary of Teleflex, Inc.).
Clearance details
- Applicant
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Product code
- Code PND
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reading, PA, US
Adverse events under product code PND
product code PND- Injury
- 149
- Malfunction
- 695
- Other
- 1
- Total
- 845
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.