Cleared Traditional

K831587 - TEMP. REPAIR KIT-DUAL LUMEN CATHETER

K831587 is an FDA 510(k) clearance for TEMP. REPAIR KIT-DUAL LUMEN CATHETER, manufactured by Norton Performance Plastics Corp.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K831587 · Norton Performance Plastics Corp. · General Hospital
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Oct 1983
Decision
155d
Days
Class 2
Risk

K831587 is an FDA 510(k) clearance for the TEMP. REPAIR KIT-DUAL LUMEN CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Norton Performance Plastics Corp. (Walker, US). The FDA issued a Cleared decision on October 19, 1983 after a review of 155 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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. Standard predicate reliance. 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 Norton Performance Plastics Corp. devices

FDA 510(k) Submission Details - K831587

510(k) Number K831587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1983
Decision Date October 19, 1983
Days to Decision 155 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 129d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 260
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K831587.
LIFE VAC #2191 & 2192
K831802 · Exco, Inc. · Jan 1984
RAAF CATHETER REPAIR KIT
K832580 · Quinton, Inc. · Jan 1984
REPAIR KITS FOR RIGHT ATRIAL CATH
K832774 · Quinton, Inc. · Jan 1984
PER-Q-CATH TRAY
K831845 · Gesco Intl., Inc. · Aug 1983
PERM. REPAIR KIT FOR LEONARD NORTON DUAL
K830969 · Norton Performance Plastics Corp. · Apr 1983