GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
FDA 510(k) clearance K152913 · decided 2016-07-21
Clearance details
- K-number
- K152913
- Device name
- GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
- Applicant
- Creganna Medical Aslo Business AS Cregganna Tactx Medical
- Decision
- Substantially Equivalent
- Date received
- 2015-10-02
- Decision date
- 2016-07-21
- Days to decision
- 293 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Galway, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access recall (Z-2249-2023) | Creganna Medical Devices | 2023-07-28 |