Cleared Traditional

K931514 - SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY

K931514 is an FDA 510(k) clearance for SCIMED ENTRE(TM) II PTCA GUIDE WIRE & A..., 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 91-day FDA review.

K931514 · Scimed Life Systems, Inc. · Cardiovascular device
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Jun 1993
Decision
91d
Days
Class 2
Risk

K931514 is an FDA 510(k) clearance for the SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Maple Grove, US). The FDA issued a Cleared decision on June 25, 1993 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 Scimed Life Systems, Inc. devices

FDA 510(k) Submission Details - K931514

510(k) Number K931514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1993
Decision Date June 25, 1993
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.

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 K931514.
NEW HYDROPHILIC COATING FOR WIRE GUIDES
K924385 · Arrow Intl., Inc. · Aug 1993
PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE
K931327 · Peripheral Systems Group · Jul 1993
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER KIT
K930787 · Advanced Surgical, Inc. · Jul 1993
SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI
K931577 · Schneider Intl., Ltd. · Jun 1993
TERUMO CORONARY GUIDE WIRE
K925852 · Terumo Medical Corp. · Jun 1993
DOC-TITE(TM) GUIDE WIRE EXTENSION
K931171 · Advanced Cardiovascular Systems, Inc. · Jun 1993