Cleared Traditional

K915496 - DESERET GUIDEWIRE INTRODUCER

K915496 is the FDA 510(k) clearance for DESERET GUIDEWIRE INTRODUCER by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K915496 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
80d
Days
Class 2
Risk

K915496 is an FDA 510(k) clearance for the DESERET GUIDEWIRE INTRODUCER. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sandy, US). The FDA issued a Cleared decision on February 27, 1992 after a review of 80 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K915496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1991
Decision Date February 27, 1992
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
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 518
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K915496.
.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE
K915723 · Advanced Cardiovascular Systems, Inc. · Jun 1992
GUIDE WIRES, MODIFICATION
K914986 · E-Z-Em, Inc. · May 1992
STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES
K914531 · Arrow Intl., Inc. · Feb 1992
GUIDER DASHER
K915115 · Target Therapeutics · Feb 1992
GUIDER, DASHER
K914030 · Target Therapeutics · Feb 1992
GUIDER-22
K914031 · Target Therapeutics · Feb 1992