Cleared Traditional

K960422 - PRUITT SAFETY OCCLUSION CATHETER

K960422 is an FDA 510(k) clearance for PRUITT SAFETY OCCLUSION CATHETER, manufactured by Ideas For Medicine, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K960422 · Ideas For Medicine, Inc. · Cardiovascular device
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Aug 1996
Decision
191d
Days
Class 2
Risk

K960422 is an FDA 510(k) clearance for the PRUITT SAFETY OCCLUSION CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Ideas For Medicine, Inc. (Clearwater, US). The FDA issued a Cleared decision on August 7, 1996 after a review of 191 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Ideas For Medicine, Inc. devices

FDA 510(k) Submission Details - K960422

510(k) Number K960422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1996
Decision Date August 07, 1996
Days to Decision 191 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 125d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJN Device Classification - Class 2, Special Controls

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - MJN Catheter, Intravascular Occluding, Temporary

All 80
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K960422.
TEMPORARY OCCLUSION BALLOON SYSTEM
K972777 · Percu Surge, Inc. · Mar 1998
CHASE VESSEL OCCLUDER
K964390 · Chase Medical, Inc. · Jan 1997
PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F
K960715 · Ideas For Medicine, Inc. · Sep 1996
OCCLUSION BALLOON CATHETER
K960832 · Interventional Therapeutics Corp. · May 1996
LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CAHTETER
K955499 · Lucas Medical, Inc. · Feb 1996
RMI NORMOCLUDER CORONARY ARTERY OCCLUDER
K915869 · Research Medical, Inc. · Dec 1992