Vascular Technology Incorporated
Medical device manufacturer in Nashua, NH.
11510(k) clearances
0PMA approvals
5recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K082870 | Vti Intraoperative Doppler SystemsDPW · Special | 10/28/2008SE |
| K031091 | Vti 20 MHZ Gated DopplerDPW · Traditional | 04/23/2003SE |
| K002990 | Vti Adult Disposable Skull Pin, Model 22000; Vti Skull Screw, Model 22001HBL · Traditional | 11/06/2000SE |
| K944764 | Vti Disposable Pressure Display SetDXS · Traditional | 12/27/1994SE |
| K922738 | Vti Oxygen AnalyzerCCL · Traditional | 01/27/1993SE |
| K890058 | Vascular Technology Uniox Oxygen AlarmCCL · Traditional | 11/21/1989SE |
| K883960 | Giphy MonitorFFT · Traditional | 10/04/1989SE |
| K864583 | Cardiac Performance MonitorDQK · Traditional | 05/11/1987SE |
| K862114 | Khuri Regional Tissue PH MonitorCBZ · Traditional | 06/25/1986SE |
| K862113 | No. 100352 Galvanic Oxygen SensorCCL · Traditional | 06/19/1986SE |
| K852275 | Vascular Tech # 100123 Polarographic Oxgyen SensorCCL · Traditional | 06/20/1985SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-3026-2018 Class II | VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910…Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver | 06/19/2018Terminated |
| Z-2001-2014 Class II | VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppler probe is…Report of the product penetrating the sterile barrier; this could render the product unsterile. | 05/28/2014Terminated |
| Z-2000-2014 Class II | 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is…Report of the product penetrating the sterile barrier; this could render the product unsterile. | 05/28/2014Terminated |
| Z-1999-2014 Class II | 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended…Report of the product penetrating the sterile barrier; this could render the product unsterile. | 05/28/2014Terminated |
| Z-1998-2014 Class II | 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended…Report of the product penetrating the sterile barrier; this could render the product unsterile. | 05/28/2014Terminated |