Cleared Traditional

K941895 - SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING

K941895 is an FDA 510(k) clearance for SCIMED 0.014 PTCA GUIDE WIRE WITH ICE H..., 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 36-day FDA review.

K941895 · Scimed Life Systems, Inc. · Cardiovascular device
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May 1994
Decision
36d
Days
Class 2
Risk

K941895 is an FDA 510(k) clearance for the SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING. 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 May 24, 1994 after a review of 36 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scimed Life Systems, Inc. devices

FDA 510(k) Submission Details - K941895

510(k) Number K941895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1994
Decision Date May 24, 1994
Days to Decision 36 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
89d faster than avg
Panel avg: 125d · This submission: 36d
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 K941895.
ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE
K942066 · Advanced Cardiovascular Systems, Inc. · Jul 1994
PLATINUM PLUS GUIDEWIRE
K935997 · Boston Scientific Corp · Jun 1994
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES
K941485 · Cardio Metrics, Inc. · May 1994
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