Vascular Technology Incorporated
Nashua, NH, US
VASCULAR TECHNOLOGY INCORPORATED appears in FDA device records in Nashua, NH. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Vascular Technology Incorporated carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Vascular Technology, Inc.enforcement report, recall
510(k) clearance history
FDA records hold 11 510(k) clearances for Vascular Technology Incorporated between 1985 and 2008. The busiest year on record is 1986, with 2. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 2 |
| 1987 | 1 |
| 1989 | 2 |
| 1993 | 1 |
| 1994 | 1 |
| 2000 | 1 |
| 2003 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082870 | VTI INTRAOPERATIVE DOPPLER SYSTEMS | DPW | Substantially Equivalent | |
| K031091 | VTI 20 MHZ GATED DOPPLER | DPW | Substantially Equivalent | |
| K002990 | VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 | HBL | Substantially Equivalent | |
| K944764 | VTI DISPOSABLE PRESSURE DISPLAY SET | DXS | Substantially Equivalent | |
| K922738 | VTI OXYGEN ANALYZER | CCL | Substantially Equivalent | |
| K890058 | VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM | CCL | Substantially Equivalent | |
| K883960 | GIPHY MONITOR | FFT | Substantially Equivalent | |
| K864583 | CARDIAC PERFORMANCE MONITOR | DQK | Substantially Equivalent | |
| K862114 | KHURI REGIONAL TISSUE PH MONITOR | CBZ | Substantially Equivalent | |
| K862113 | NO. 100352 GALVANIC OXYGEN SENSOR | CCL | Substantially Equivalent | |
| K852275 | VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR | CCL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1221072 | 1221072 | VASCULAR TECHNOLOGY INCORPORATED | 12 MURPHY DR., NASHUA, NH 03062 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- CBZAnalyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- DQKComputer, Diagnostic, Programmable
- FFTElectrode, Ph, Stomach
- DPWFlowmeter, Blood, Cardiovascular
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass
- HBLHolder, Head, Neurosurgical (Skull Clamp)
- GCJLaparoscope, General & Plastic Surgery
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3026-2018 | VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular. | Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver | Class II | Terminated | |
| Z-2001-2014 | 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. | Report of the product penetrating the sterile barrier; this could render the product unsterile. | Class II | Terminated | |
| Z-2000-2014 | 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. | Report of the product penetrating the sterile barrier; this could render the product unsterile. | Class II | Terminated | |
| Z-1999-2014 | 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. | Report of the product penetrating the sterile barrier; this could render the product unsterile. | Class II | Terminated | |
| Z-1998-2014 | 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. | Report of the product penetrating the sterile barrier; this could render the product unsterile. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain
