Cleared Traditional

K924591 - SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER

K924591 is an FDA 510(k) clearance for SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER, manufactured by Schneider Intl., Ltd.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K924591 · Schneider Intl., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
89d
Days
Class 2
Risk

K924591 is an FDA 510(k) clearance for the SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Schneider Intl., Ltd. (Plymouth, US). The FDA issued a Cleared decision on December 8, 1992 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Schneider Intl., Ltd. devices

FDA 510(k) Submission Details - K924591

510(k) Number K924591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1992
Decision Date December 08, 1992
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 601
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K924591.
TRIGUIDE-PLUS GUIDING CATHETER
K923245 · Scimed Life Systems, Inc. · Feb 1993
GUIDING CATHETER
K923518 · Interventional Therapeutics Corp. · Jan 1993
SCIMED 6 FR. TRIGUIDE - ELITE GUIDING CATHETER
K922611 · Scimed Life Systems, Inc. · Jan 1993
CORDIS SHUTTLE CATHETER W/ SIDEHOLES
K921311 · Cordis Corp. · Sep 1992
E-Z-FLOW ANGIOGRAPHY CATHETERS, MODIFICATION
K914984 · E-Z-Em, Inc. · May 1992
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
K914856 · Cook, Inc. · May 1992