Cleared Special

K100789 - MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST

K100789 is an FDA 510(k) clearance for MODIFICATON TO: STEERABLE GUIDE CATHETER, manufactured by Evalve, Inc.. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Special 510(k) pathway after a 30-day FDA review.

K100789 · Evalve, Inc. · Cardiovascular device
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Apr 2010
Decision
30d
Days
Class 2
Risk

K100789 is an FDA 510(k) clearance for the MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST. 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 21, 2010 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Evalve, Inc. devices

FDA 510(k) Submission Details - K100789

510(k) Number K100789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2010
Decision Date April 21, 2010
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 21
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K100789.
AcQGuide Steerable Sheath
K162925 · Acutus Medical, Inc. · Apr 2017
Steerable Guide Catheter
K161985 · Abbott Vascular · Aug 2016
STEERABLE GUIDE CATHETER
K112239 · Abbott Vascular · Aug 2011
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
K052575 · St Jude Medical · Jan 2006
LYSUS INFUSION SYSTEM
K050472 · Ekos Corp. · Mar 2005
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
K040165 · St Jude Medical · May 2004