Cleared Traditional

K955637 - ESSENCE GUIDEWIRE

K955637 is the FDA 510(k) clearance for ESSENCE GUIDEWIRE by Cordis Neurovascular, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K955637 · Cordis Neurovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
91d
Days
Class 2
Risk

K955637 is an FDA 510(k) clearance for the ESSENCE GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cordis Neurovascular, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on March 11, 1996 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Cordis Neurovascular, Inc. devices

Submission Details

510(k) Number K955637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1995
Decision Date March 11, 1996
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 493
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K955637.
SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES
K960563 · Scimed Life Systems, Inc. · Apr 1996
SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE
K960657 · Scimed Life Systems, Inc. · Apr 1996
ACS ANCHOR EXCHANGE DEVICE
K955175 · Advanced Cardiovascular Systems, Inc. · Apr 1996
RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD
K955801 · Terumo Medical Corp. · Feb 1996
GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS
K943896 · Datascope Corp. · Dec 1995
CORDIS WIZDOM STEERABLE GUIDEWIRE
K953760 · Cordis Corp. · Nov 1995