Company ยท US
Vascular Technology Incorporated
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2008. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | 7 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 4 |
| CBZ | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 |
| DXS | Gauge, Pressure, Coronary, Cardiopulmonary Bypass | 1 |
| FFT | Electrode, Ph, Stomach | 1 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 28, 2008 | K082870 | VTI INTRAOPERATIVE DOPPLER SYSTEMS Vascular Technology Incorporated | DPW |
| Apr 23, 2003 | K031091 | VTI 20 MHZ GATED DOPPLER Vascular Technology Incorporated | DPW |
| Nov 6, 2000 | K002990 | VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 Vascular Technology Incorporated | HBL |
| Dec 27, 1994 | K944764 | VTI DISPOSABLE PRESSURE DISPLAY SET Vascular Technology Incorporated | DXS |
| Jan 27, 1993 | K922738 | VTI OXYGEN ANALYZER Vascular Technology Incorporated | CCL |
| Nov 21, 1989 | K890058 | VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM Vascular Technology Incorporated | CCL |
| Oct 4, 1989 | K883960 | GIPHY MONITOR Vascular Technology Incorporated | FFT |
| May 11, 1987 | K864583 | CARDIAC PERFORMANCE MONITOR Vascular Technology Incorporated | DQK |
| Jun 25, 1986 | K862114 | KHURI REGIONAL TISSUE PH MONITOR Vascular Technology Incorporated | CBZ |
| Jun 19, 1986 | K862113 | NO. 100352 GALVANIC OXYGEN SENSOR Vascular Technology Incorporated | CCL |
| Jun 20, 1985 | K852275 | VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR Vascular Technology Incorporated | CCL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2018 | Vascular Technology, Inc. VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel
Ref. Number: 108910
Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic Terminated |
DPW | K031091 |
| Jul 7, 2014 | Vascular Technology, Inc. VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660
The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow. Terminated |
DPW | K082870 |
| Jul 7, 2014 | Vascular Technology, Inc. 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665
The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow. Terminated |
DPW | K082870 |
| Jul 7, 2014 | Vascular Technology, Inc. 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660
The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow. Terminated |
DPW | K082870 |
| Jul 7, 2014 | Vascular Technology, Inc. 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200
The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow. Terminated |
DPW | K082870 |