Cleared Traditional

GUIDEWIRE INTRODUCER SET (K915421) - FDA 510(k) Clearance

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

K915421 · B. Braun of America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
87d
Days
Class 2
Risk

K915421 is an FDA 510(k) clearance for the GUIDEWIRE INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on February 27, 1992 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 B. Braun of America, Inc. devices

Submission Details

510(k) Number K915421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1991
Decision Date February 27, 1992
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 259
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K915421.
CATHETER INTRODUCER
K920528 · Boston Scientific Corp · Aug 1992
GORE TUNNELER, MODIFICATION
K920998 · W.L. Gore & Associates, Inc. · Jun 1992
USCI HEMAQUET XT INTRODUCER
K920251 · C.R. Bard, Inc. · Mar 1992
USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING
K915553 · C.R. Bard, Inc. · Feb 1992
CORDIS OBTURATOR
K914352 · Cordis Corp. · Nov 1991
CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL
K913801 · Cordis Corp. · Oct 1991