510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K121006Substantially Equivalent

Ensite Array Multi-Electrode Diagnostic Catheter

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

K121006 is the FDA 510(k) clearance record for ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER, a class II device, cleared for St Jude Medical on under FDA product code MTD (Catheter, Intracardiac Mapping, High-Density Array). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K121006.

Clearance record

Decision date
Received
(30 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
St Jude Medical 14901 Deveau Pl., Minnetonka MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MTD

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