Cleared Traditional

K980360 - SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES

K980360 is an FDA 510(k) clearance for SCIMED QUEST FLOPPY AND MODERATE SUPPOR..., 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.

K980360 · Scimed Life Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
90d
Days
Class 2
Risk

K980360 is an FDA 510(k) clearance for the SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES. 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 April 29, 1998 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 - K980360

510(k) Number K980360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1998
Decision Date April 29, 1998
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 K980360.
ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1
K981381 · Guidant Corp. · Jul 1998
LAKE REGION MANUFACTURING GUIDEWIRES
K981326 · Lake Region Mfg., Inc. · Jul 1998
CORDIS VANGUARD STEERABLE GUIDEWIRES
K974560 · Cordis Corp. · May 1998
PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE
K972793 · Radi Medical Systems AB · Apr 1998
ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K980294 · Guidant Corp. · Apr 1998
ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE
K980119 · Guidant Corp. · Mar 1998