VTI INTRAOPERATIVE DOPPLER SYSTEMS
FDA 510(k) clearance K082870 · decided 2008-10-28
Clearance details
- K-number
- K082870
- Device name
- VTI INTRAOPERATIVE DOPPLER SYSTEMS
- Applicant
- Vascular Technology Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2008-09-29
- Decision date
- 2008-10-28
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DPW
- Device class
- 2
- Regulation number
- 870.2100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Nashua, NH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended fo recall (Z-1998-2014) | Vascular Technology, Inc. | 2014-07-07 |
| 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for recall (Z-1999-2014) | Vascular Technology, Inc. | 2014-07-07 |
| 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended recall (Z-2000-2014) | Vascular Technology, Inc. | 2014-07-07 |
| VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is inte recall (Z-2001-2014) | Vascular Technology, Inc. | 2014-07-07 |