510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K915496Substantially Equivalent

Deseret Guidewire Introducer

BD Becton Dickinson Vacutainer Systems Preanalytic, Sandy UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915496 is the FDA 510(k) clearance record for DESERET GUIDEWIRE INTRODUCER, a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K915496.

Clearance record

Decision date
Received
(80 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 9450 S. State Sreet, Sandy UT
510(k) summary
Summary
Third party review
No

Clearances, product code DQX

Trailing 12 months
12 clearances under product code DQX in the twelve months to November 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20261
November 20260