510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K192037Substantially Equivalent

Advisor VL Circular Mapping Catheter, Sensor Enabled

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

K192037 is the FDA 510(k) clearance record for Advisor VL Circular Mapping Catheter, Sensor Enabled, a class II device, cleared for ABBOTT MEDICAL on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list 1,478 510(k) clearances for ABBOTT MEDICAL, from to . As of , FDA records show no recalls naming K192037.

Clearance record

Decision date
Received
(49 days to decision)
Product code
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
Abbott Medical 5050 Nathan Ln. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRF

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