Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.
FDA 510(k) clearance K171146 · decided 2017-06-23
Clearance details
- K-number
- K171146
- Device name
- Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.
- Applicant
- Arrow International, Inc. (Subsidiary of Telelflex Inc.)
- Decision
- Substantially Equivalent
- Date received
- 2017-04-19
- Decision date
- 2017-06-23
- Days to decision
- 65 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- 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: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3 recall (Z-2377-2026) | ARROW INTERNATIONAL, LLC | 2026-06-13 |