Cleared Traditional

K040165 - REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805

K040165 is an FDA 510(k) clearance for REFLEXION CANNULATOR STEERABLE ELECTROP..., manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K040165 · St Jude Medical · Cardiovascular device
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May 2004
Decision
107d
Days
Class 2
Risk

K040165 is an FDA 510(k) clearance for the REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 4.... Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by St Jude Medical (Minnetonka, US). The FDA issued a Cleared decision on May 12, 2004 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all St Jude Medical devices

FDA 510(k) Submission Details - K040165

510(k) Number K040165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2004
Decision Date May 12, 2004
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRA Device Classification - Class 2, Special Controls

Product Code DRA Catheter, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1280
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRA Catheter, Steerable

All 30
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K040165.
FLEXCATH STEERABLE SHEATH & DILATOR
K070357 · Cryocath Technologies, Inc. · Dec 2007
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
K052575 · St Jude Medical · Jan 2006
LYSUS INFUSION SYSTEM
K050472 · Ekos Corp. · Mar 2005
RESPONSE(TM) STEERABLE CATHETER
K913940 · Daig Corp. · Jan 1993
ADULT VENT CATHETER
K834352 · Dlp, Inc. · Jan 1984