510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K193194Substantially Equivalent

CrossTorq 14 Guidewire

Scientia Cardio Access, LLC, West Valley City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193194 is the FDA 510(k) clearance record for CrossTorq 14 Guidewire, a class II device, cleared for Scientia Cardio Access, LLC on under FDA product code DQX (Wire, Guide, Catheter). FDA records list one 510(k) clearance for Scientia Cardio Access, LLC. As of , FDA records show no recalls naming K193194.

Clearance record

Decision date
Received
(24 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Scientia Cardio Access, LLC 3487 W. 2100 S., Suite 100, West Valley City UT
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DQX

Trailing 12 months
12 clearances under product code DQX in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20260