Data / Medical devices / United States / Vascular Technology Incorporated
Vascular Technology Incorporated: FDA-registered device maker in Nashua, NH, United States, 2 510(k) clearances
Vascular Technology Incorporated is registered with the FDA (registration 1221072) in Nashua, NH, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 4, 2014. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1221072
- Address
- 12 Murphy DR., Nashua, NH, United States, 03062
- Owner or operator
- VASCULAR TECHNOLOGY INCORPORATED (1221072)
- Roles
- Manufacturer
- First device listed
- October 15, 2009
- Registered through
- 2027
- Brand names listed
- 07-150-02 Mizuho 20 MHz Surgical Doppler Transceiver, 07-150-08 Mizuho Doppler 8 MHz Dual Channel, AC Power, 07-150-20 Mizuho 20 MHz Surgical Doppler Transceiver, AC, 20MHz Micro Disposable Doppler Probe, 8 MHz Kelly Endonasal Disposable Doppler Probe, Box, Cuff:Inflation for ROSI, Edwards FLO-002S Ultrasonic Blood Flow Detector Curved Probe, Box, Edwards FLO-003S Ultrasonic Blood Flow Detector Straight Probe, Box and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Flowmeter, Blood, Cardiovascular | DPW | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 4, 2014 | K141323 | VTI SUCTION IRRIGATION SYSTEM | GCJ | Substantially Equivalent | Regulatory Technology Services, LLC | accessdata.fda.gov |
| October 28, 2008 | K082870 | VTI INTRAOPERATIVE DOPPLER SYSTEMS | DPW | Substantially Equivalent | Vascular Technology Incorporated | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 19, 2018 | 80527 | Class II | Terminated | 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 | accessdata.fda.gov |
| May 28, 2014 | 68512 | Class II | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
Updated June 4, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.