Cleared Traditional

K915625 - INTRODUCER CATHETER

K915625 is the FDA 510(k) clearance for INTRODUCER CATHETER by Interventional Therapeutics Corp.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K915625 · Interventional Therapeutics Corp. · Cardiovascular device
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Jun 1992
Decision
176d
Days
Class 2
Risk

K915625 is an FDA 510(k) clearance for the INTRODUCER CATHETER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Interventional Therapeutics Corp. (South San Francisco, US). The FDA issued a Cleared decision on June 3, 1992 after a review of 176 days - an extended review 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: 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 Interventional Therapeutics Corp. devices

Submission Details

510(k) Number K915625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1991
Decision Date June 03, 1992
Days to Decision 176 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 125d · This submission: 176d
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 325
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K915625.
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K924607 · Arrow Intl., Inc. · Apr 1993
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