Cleared Traditional

K945379 - PLATINUM PLUS GUIDEWIRE WITH HYDROPHILI...

K945379 is the FDA 510(k) clearance for PLATINUM PLUS GUIDEWIRE WITH HYDROPHILI... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K945379 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
215d
Days
Class 2
Risk

K945379 is an FDA 510(k) clearance for the PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on June 5, 1995 after a review of 215 days - an extended review 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: 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 Boston Scientific Corp devices

Submission Details

510(k) Number K945379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1994
Decision Date June 05, 1995
Days to Decision 215 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
90d slower than avg
Panel avg: 125d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 498
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K945379.
URESIL(R) GUIDEWIRE
K945934 · Uresil Corp. · Jul 1995
SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE
K950216 · Scimed Life Systems, Inc. · Jun 1995
BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES
K951307 · Baxter Healthcare Corp · Jun 1995
NAVIGUIDE HYDROPHILIC GUIDE WIRE
K943358 · Meadox Medicals, Div. Boston Scientific Corp. · Jun 1995
SCIMED CHOICE PT PTCA GUIDE WIRE
K950835 · Scimed Life Systems, Inc. · May 1995
ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS
K950752 · Advanced Cardiovascular Systems, Inc. · May 1995