Cleared Traditional

K832774 - REPAIR KITS FOR RIGHT ATRIAL CATH

K832774 is an FDA 510(k) clearance for REPAIR KITS FOR RIGHT ATRIAL CATH, manufactured by Quinton, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K832774 · Quinton, Inc. · General Hospital
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Jan 1984
Decision
140d
Days
Class 2
Risk

K832774 is an FDA 510(k) clearance for the REPAIR KITS FOR RIGHT ATRIAL CATH. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 140 days - within the typical 510(k) review window.

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 Quinton, Inc. devices

FDA 510(k) Submission Details - K832774

510(k) Number K832774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1983
Decision Date January 03, 1984
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
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 266
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K832774.
RAAF DUAL LUMEN CATH. REPAIR KIT 2.2
K834225 · Quinton, Inc. · Feb 1984
LIFE VAC #2191 & 2192
K831802 · Exco, Inc. · Jan 1984
RAAF CATHETER REPAIR KIT
K832580 · Quinton, Inc. · Jan 1984
TEMP. REPAIR KIT-DUAL LUMEN CATHETER
K831587 · Norton Performance Plastics Corp. · Oct 1983
PER-Q-CATH TRAY
K831845 · Gesco Intl., Inc. · Aug 1983
PERM. REPAIR KIT FOR LEONARD NORTON DUAL
K830969 · Norton Performance Plastics Corp. · Apr 1983