Cleared Traditional

K950047 - SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER

K950047 is an FDA 510(k) clearance for SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE E..., manufactured by Isomedix Operations, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K950047 · Isomedix Operations, Inc. · Cardiovascular device
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Apr 1995
Decision
90d
Days
Class 2
Risk

K950047 is an FDA 510(k) clearance for the SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Isomedix Operations, Inc. (Libertyville, US). The FDA issued a Cleared decision on April 5, 1995 after a review of 90 days - within the typical 510(k) review window.

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: 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 Isomedix Operations, Inc. devices

FDA 510(k) Submission Details - K950047

510(k) Number K950047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1995
Decision Date April 05, 1995
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 690
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