VTI 20 MHZ GATED DOPPLER— 510(k) K031091

Name: FDA 510(k) clearance K031091
Creator: U.S. Food and Drug Administration
Published: 2003-04-23

Substantially Equivalent

Vascular Technology Incorporated

FDA 510(k) clearance K031091 for VTI 20 MHZ GATED DOPPLER, Substantially Equivalent on 2003-04-23. Applicant: Vascular Technology Incorporated. Device class: 2.

Clearance details

Applicant: Vascular Technology Incorporated
Product code: Code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 2003-04-07
Decision date: 2003-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lowell, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPW

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K251114 — FloPatch FP1202025-06-20
K243852 — Elfor-L2025-04-14

More clearances from Vascular Technology Incorporated

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K082870 — VTI INTRAOPERATIVE DOPPLER SYSTEMS2008-10-28
K002990 — VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 220012000-11-06
K944764 — VTI DISPOSABLE PRESSURE DISPLAY SET1994-12-27
K922738 — VTI OXYGEN ANALYZER1993-01-27
K890058 — VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM1989-11-21

Recalls naming K031091

K-number listed on FDA's recall record

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.Class II·Terminated·Vascular Technology, Inc.·20180619

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031091.

Data sourced from openFDA. This site is unofficial and independent of the FDA.