Cleared Traditional

K083793 - STEERABLE GUIDE CATHETER

K083793 is an FDA 510(k) clearance for STEERABLE GUIDE CATHETER, manufactured by Evalve, Inc.. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K083793 · Evalve, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
126d
Days
Class 2
Risk

K083793 is an FDA 510(k) clearance for the STEERABLE GUIDE CATHETER. Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Evalve, Inc. (Menlo Park, US). The FDA issued a Cleared decision on April 27, 2009 after a review of 126 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 - K083793

510(k) Number K083793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date April 27, 2009
Days to Decision 126 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
1d slower than avg
Panel avg: 125d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00209274 Completed Interventional Industry-sponsored

Pivotal Study of a Percutaneous Mitral Valve Repair System

Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)

279
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Mitral Valve Insufficiency; Mitral Valve Regurgitation; Mitral Valve Incompetence; Mitral Regurgitation; Mitral Insufficiency
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Ted Feldman, M.D.
Sponsor Abbott Medical Devices (industry)
Started 2005-08-01 → Primary completion 2009-11-01 → Completed 2014-12-01
Primary outcome
Number of Participants With Major Adverse Events (MAE)
Secondary outcome
Freedom From All-Cause Mortality
View full study on ClinicalTrials.gov

Regulatory Peers - DRA Catheter, Steerable

All 40
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K083793.
MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST
K100789 · Evalve, Inc. · Apr 2010
EVALVE STEERABLE GUIDE CATHETER
K093866 · Evalve, Inc. · Jan 2010
EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST
K091596 · Evalve, Inc. · Jul 2009
FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
K081049 · Cryocath Technologies, Inc. · Jun 2008
FLEXCATH STEERABLE SHEATH & DILATOR
K070357 · Cryocath Technologies, Inc. · Dec 2007
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
K052575 · St Jude Medical · Jan 2006
K083793 · STEERABLE GUIDE CATHETER
Download PDF FDA Summary Evalve, Inc.