Cleared Traditional

K935905 - SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP

K935905 is an FDA 510(k) clearance for SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP, manufactured by Scimed Life Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K935905 · Scimed Life Systems, Inc. · Cardiovascular device
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Mar 1994
Decision
90d
Days
Class 2
Risk

K935905 is an FDA 510(k) clearance for the SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 10, 1994 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 870.1330 - 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 Scimed Life Systems, Inc. devices

FDA 510(k) Submission Details - K935905

510(k) Number K935905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1993
Decision Date March 10, 1994
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

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 686
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K935905.
ONTRAC STEERABLE GUIDEWIRE
K941229 · Lake Region Mfg., Inc. · May 1994
CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS
K935170 · Lake Region Mfg., Inc. · Mar 1994
TORQUE DEVICE
K936032 · Merit Medical Systems, Inc. · Mar 1994
ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE
K930982 · Cordis Corp. · Feb 1994
SCIMED ENTRE II PTCA GUIDE WIRE
K935577 · Scimed Life Systems, Inc. · Feb 1994
MAGIC TORQUE GUIDEWIRE
K933334 · Boston Scientific Corp · Jan 1994