Cleared Traditional

K950201 - ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER (FDA 510(k) Clearance)

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

K950201 · Sherwood Medical Co. · General Hospital
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Dec 1995
Decision
331d
Days
Class 2
Risk

K950201 is an FDA 510(k) clearance for the ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on December 15, 1995 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sherwood Medical Co. devices

Submission Details

510(k) Number K950201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1995
Decision Date December 15, 1995
Days to Decision 331 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 128d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOL Catheter And Tip, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 General Hospital devices follow this clearance model.