Cleared Traditional

K961336 - MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652

K961336 is an FDA 510(k) clearance for MEDTRONIC VASCULAR CATHETER, manufactured by Medtronic PS Medical. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K961336 · Medtronic PS Medical · General Hospital
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Jul 1996
Decision
101d
Days
Class 2
Risk

K961336 is an FDA 510(k) clearance for the MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Medtronic PS Medical (Goleta, US). The FDA issued a Cleared decision on July 18, 1996 after a review of 101 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 Medtronic PS Medical devices

FDA 510(k) Submission Details - K961336

510(k) Number K961336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1996
Decision Date July 18, 1996
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
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 224
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K961336.
CATHETER INSERTION TRAY
K962849 · Medcare Medical Group, Inc. · Oct 1996
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K960055 · Pudenz-Schulte Medical Research Corp. · Sep 1996
CLAMPLESS VALVED CATHETER
K962300 · Bmw Medical, Inc. · Sep 1996
AUTO SUTURE CHEMOSITE TUNNELER
K961856 · United States Surgical, A Division of Tyco Healthc · Jul 1996
SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908
K961155 · Douglas Medical Products Corp. · Jun 1996
VYGON PREMI-CATH - LONG TERM CATHETER
K954302 · Vygon Corp. · Jun 1996