Cleared Traditional

K993376 - ENSTYLET MODELS EC0010, EC0020

K993376 is an FDA 510(k) clearance for ENSTYLET MODELS EC0010, manufactured by Endocardial Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K993376 · Endocardial Solutions, Inc. · Cardiovascular device
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Jan 2000
Decision
90d
Days
Class 2
Risk

K993376 is an FDA 510(k) clearance for the ENSTYLET MODELS EC0010, EC0020. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Endocardial Solutions, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 5, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1380 - 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 Endocardial Solutions, Inc. devices

FDA 510(k) Submission Details - K993376

510(k) Number K993376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1999
Decision Date January 05, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRB Device Classification - Class 2, Special Controls

Product Code DRB Stylet, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1380
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 - DRB Stylet, Catheter

All 17
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K993376.
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular · Apr 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · Medtronic Vascular · Feb 2001
PLACER MODEL 6232 STEERABLE STYLET
K000955 · Medtronic Vascular · Jun 2000
LEAD STYLET,MODELS 6505,6506,6507,6508
K992863 · Guidant Corp. · Nov 1999
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER
K990713 · Spectranetics Corp. · Oct 1999
TARGET THERAPEUTICS RADIOPAQUE STYLET
K914001 · Target Therapeutics · Nov 1991