Cleared Traditional

DESERET GUIDEWIRE INTRODUCER II (K920407) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K920407 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
67d
Days
Class 2
Risk

K920407 is an FDA 510(k) clearance for the DESERET GUIDEWIRE INTRODUCER II. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sandy, US). The FDA issued a Cleared decision on April 7, 1992 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 K920407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1992
Decision Date April 07, 1992
Days to Decision 67 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
58d faster than avg
Panel avg: 125d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 152
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K920407.
USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT
K920980 · C.R. Bard, Inc. · Aug 1992
CARDIAC CATHERIZATION KIT
K914299 · Abbott Laboratories · Jun 1992
CORDIS ANGIOGRAPHIC DOPPLER CATHER
K915498 · Cordis Corp. · Apr 1992
DESERET GUIDEWIRE INTRODUCER III
K920408 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS
K915836 · Cordis Corp. · Feb 1992
TERUMO ANGIOGTAPHIC CATHETER
K915414 · Terumo Medical Corp. · Feb 1992