Cleared Traditional

K946240 - SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE

K946240 is an FDA 510(k) clearance for SCIMED SCEPTOR(TM) PTCA GUIDE WIRE, 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 99-day FDA review.

K946240 · Scimed Life Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
99d
Days
Class 2
Risk

K946240 is an FDA 510(k) clearance for the SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIRE. 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 31, 1995 after a review of 99 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 - K946240

510(k) Number K946240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1994
Decision Date March 31, 1995
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
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 K946240.
CORDIS STEERABLE GUIDEWIRES
K950316 · Cordis Corp. · Apr 1995
DASHER-14
K950069 · Target Therapeutics · Apr 1995
ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE
K950156 · Advanced Cardiovascular Systems, Inc. · Apr 1995
M-PATH NITINOL GUIDEWIRE
K946356 · Microvena Corp. · Mar 1995
SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIRE
K950113 · Scimed Life Systems, Inc. · Mar 1995
SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE
K950141 · Scimed Life Systems, Inc. · Mar 1995