REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804— 510(k) K062251

Name: FDA 510(k) clearance K062251
Creator: U.S. Food and Drug Administration
Published: 2006-10-20

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K062251 for REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804, Substantially Equivalent on 2006-10-20. Applicant: St Jude Medical. Device class: 2.

Clearance details

Applicant: St Jude Medical
Product code: Code DRF
Device class: Class 2
Regulation: 21 CFR 870.1220
Advisory panel: Cardiovascular
Date received: 2006-08-03
Decision date: 2006-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRF

view all

K252794 — Vision-MR Diagnostic Catheter2026-01-08
K250590 — MAGiC Sweep EP Mapping Catheter2025-07-23
K250310 — VIKING Fixed Curve Diagnostic Catheter2025-06-27
K240366 — EPXT Unidirectional Steerable Diagnostic Catheter +2 more2024-11-01
K233900 — Nordica PV Cryo Mapping Catheter2024-09-06

More clearances from St Jude Medical

view all

K181382 — GuardianTM Burr Hole Cover System2018-07-20
K172396 — EnSite Velocity Cardiac Mapping System v5.22018-04-23
K173232 — myMerlin(TM) Mobile Application Model APP10012017-11-02
K160210 — EnSite Precision Cardiac Mapping System v2.02016-12-13
K160218 — AutoMark Module2016-12-13

Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.