510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K172393Substantially Equivalent

Advisor HD Grid Mapping Catheter, Sensor Enabled

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

K172393 is the FDA 510(k) clearance record for Advisor HD Grid Mapping Catheter, Sensor Enabled, a class II device, cleared for St. Jude Medical, Inc. 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 K172393.

Clearance record

Decision date
Received
(258 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, Inc. 5050 Nathan Ln. N., Plymouth 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 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