Worker Guidewire
FDA 510(k) clearance K160785 · decided 2016-12-08
Clearance details
- K-number
- K160785
- Device name
- Worker Guidewire
- Applicant
- Argon Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-22
- Decision date
- 2016-12-08
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Athens, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208 recall (Z-1791-2020) | Argon Medical Devices, Inc | 2020-05-07 |
| 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20 recall (Z-1792-2020) | Argon Medical Devices, Inc | 2020-05-07 |