Cleared Traditional

SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER (K926003) - FDA 510(k) Clearance

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

K926003 · Schneider Intl., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
192d
Days
Class 2
Risk

K926003 is an FDA 510(k) clearance for the SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Schneider Intl., Ltd. (Plymouth, US). The FDA issued a Cleared decision on June 7, 1993 after a review of 192 days - an extended review 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: 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 Schneider Intl., Ltd. devices

Submission Details

510(k) Number K926003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1992
Decision Date June 07, 1993
Days to Decision 192 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
67d slower than avg
Panel avg: 125d · This submission: 192d
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 143
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K926003.
DYE MANAGEMENT SYSTEM
K933700 · Abbott Laboratories · Nov 1993
USCI ANGIOGRAPHIC CATHETER
K932092 · C.R. Bard, Inc. · Jul 1993
CORDIS 7 FRENCH THRULUMEN CATHETER
K922891 · Cordis Corp. · Jun 1993
NYLEX CATHETERS
K930479 · Cordis Corp. · Apr 1993
USCI LINX EZ GUIDE WIRE EXTEN. W/ PRO/PEL COATING
K922105 · C.R. Bard, Inc. · Nov 1992
PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH
K915726 · Baxter Healthcare Corp · Sep 1992