Arrow Quickflash Arterial Catheterization Device
FDA 510(k) clearance K160018 · decided 2016-06-13
Clearance details
- K-number
- K160018
- Device name
- Arrow Quickflash Arterial Catheterization Device
- Applicant
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
- Decision
- Substantially Equivalent
- Date received
- 2016-01-05
- Decision date
- 2016-06-13
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA recall (Z-2397-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |
| ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF recall (Z-1267-2024) | ARROW INTERNATIONAL Inc. | 2024-03-21 |