Y-GLIDE
FDA 510(k) clearance K072745 · decided 2008-01-04
Clearance details
- K-number
- K072745
- Device name
- Y-GLIDE
- Applicant
- Thomas Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-27
- Decision date
- 2008-01-04
- Days to decision
- 99 days
- Clearance type
- Special
- Product code
- DTL
- Device class
- 2
- Regulation number
- 870.4290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Thomas Medical Products, Y-Glide (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary By recall (Z-1225-2011) | Thomas Medical Products Inc | 2011-02-14 |
| Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis Valve recall (Z-1228-2011) | Thomas Medical Products Inc | 2011-02-14 |