510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031091Substantially Equivalent

Vti 20 Mhz Gated Doppler

Vascular Technology Incorporated, Lowell MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K031091 is the FDA 510(k) clearance record for VTI 20 MHZ GATED DOPPLER, a class II device, cleared for Vascular Technology Incorporated on under FDA product code DPW (Flowmeter, Blood, Cardiovascular). FDA records list 11 510(k) clearances for Vascular Technology Incorporated, from to . As of , FDA records show one recall naming K031091.

Clearance record

Decision date
Received
(16 days to decision)
Product code
DPW Flowmeter, Blood, Cardiovascular
Regulation
21 CFR 870.2100
Device class
Class II
Review panel
Cardiovascular
Applicant
Vascular Technology Incorporated 175 Cabot St., Lowell MA
510(k) summary
Statement
Third party review
Yes

Clearances, product code DPW

Trailing 12 months
3 clearances under product code DPW in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DPW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260