510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K142254Substantially Equivalent

CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector

Abbott Medical, Sylmar CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142254 is the FDA 510(k) clearance record for CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector, a class II device, cleared for St Jude Medical on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K142254.

Clearance record

Decision date
Received
(91 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
St Jude Medical 15900 Valley View Ct., Sylmar CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQX

Trailing 12 months
13 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 20261