510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K060954Substantially Equivalent

Modification to Ensite System, Model Ee3000

St. Jude Medical, Inc.-Endocardial Solutions, St. Paul MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060954 is the FDA 510(k) clearance record for MODIFICATION TO ENSITE SYSTEM, MODEL EE3000, a class II device, cleared for St. Jude Medical, Inc.-Endocardial Solutions on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list one 510(k) clearance for St. Jude Medical, Inc.-Endocardial Solutions. As of , FDA records show no recalls naming K060954.

Clearance record

Decision date
Received
(14 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
St. Jude Medical, Inc.-Endocardial Solutions 1350 Energy Ln., Suite 110, St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQK

Trailing 12 months
26 clearances under product code DQK in the twelve months to October 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
November 20250
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20261