ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology
FDA 510(k) clearance K161313 · decided 2016-08-24
Clearance details
- K-number
- K161313
- Device name
- ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology
- Applicant
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Decision
- Substantially Equivalent
- Date received
- 2016-05-10
- Decision date
- 2016-08-24
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- PND
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .0 recall (Z-0102-2023) | ARROW INTERNATIONAL Inc. | 2022-10-19 |