Cleared Traditional

K052575 - LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN

K052575 is an FDA 510(k) clearance for LUMINARY CANNULATOR BIDEFLECTABLE CATHE..., 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 122-day FDA review.

K052575 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
122d
Days
Class 2
Risk

K052575 is an FDA 510(k) clearance for the LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN. 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 January 19, 2006 after a review of 122 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.

FDA 510(k) Submission Details - K052575

510(k) Number K052575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2005
Decision Date January 19, 2006
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
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 41
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K052575.
STEERABLE GUIDE CATHETER
K083793 · Evalve, Inc. · Apr 2009
FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
K081049 · Cryocath Technologies, Inc. · Jun 2008
FLEXCATH STEERABLE SHEATH & DILATOR
K070357 · Cryocath Technologies, Inc. · Dec 2007
LYSUS INFUSION SYSTEM
K050472 · Ekos Corp. · Mar 2005
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
K040165 · St Jude Medical · May 2004
24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524
K012143 · Medtronic Cardiac Surgical Products · Oct 2001
K052575 · LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
Download PDF FDA Summary St Jude Medical