510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983456Unknown

Ensite 3000 System

Endocardial Solutions, Inc., St. Paul MN / Traditional, Unknown
FDA source (opens on fda.gov)

K983456 is the FDA 510(k) clearance record for ENSITE 3000 SYSTEM, a class II device, cleared for Endocardial Solutions, Inc. on under FDA product code MTD (Catheter, Intracardiac Mapping, High-Density Array). FDA records list 8 510(k) clearances for Endocardial Solutions, Inc., from to . As of , FDA records show no recalls naming K983456.

Clearance record

Decision date
Received
(203 days to decision)
Product code
MTD Catheter, Intracardiac Mapping, High-Density Array
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
Endocardial Solutions, Inc. 1350 Energy Ln., Suite 110, St. Paul MN
510(k) summary
Summary
Third party review
No

Clearances, product code MTD

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