510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K160335Substantially Equivalent

Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D

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

K160335 is the FDA 510(k) clearance record for Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D, a class II device, cleared for St Jude 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 K160335.

Clearance record

Decision date
Received
(309 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
St Jude Medical 5050 Nathan Ln., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRF

Trailing 12 months
2 clearances 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 20261