510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K040165Substantially Equivalent

Reflexion Cannulator Steerable Electrophysiology Catheter with Lumen, Model 402805

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

K040165 is the FDA 510(k) clearance record for REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805, a class II device, cleared for St Jude Medical on under FDA product code DRA (Catheter, Steerable). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K040165.

Clearance record

Decision date
Received
(107 days to decision)
Product code
DRA Catheter, Steerable
Regulation
21 CFR 870.1280
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 DRA

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