Cleared Traditional

K994141 - CATHETER

Also marketed or referenced as:
WIRE, GUIDE, CATHETER, MODEL QSW1000

K994141 is the FDA 510(k) clearance for CATHETER by Medtronic Ave, Inc.. It is a Class 2 Cardiovascular device (product code MJN) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K994141 · Medtronic Ave, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
226d
Days
Class 2
Risk

K994141 is an FDA 510(k) clearance for the CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Medtronic Ave, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on July 21, 2000 after a review of 226 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 Medtronic Ave, Inc. devices

Submission Details

510(k) Number K994141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1999
Decision Date July 21, 2000
Days to Decision 226 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 125d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 46
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K994141.
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
K010162 · Micro Therapeutics, Inc. · May 2001
PTA-OS SIZING BALLOON, MODEL 360
K003320 · NuMED, Inc. · May 2001
LDOB OCCLUSION BALLOON CATHETER
K002286 · Cook, Inc. · Mar 2001
EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO
K001237 · Micro Therapeutics, Inc. · May 2000
EQUINOX OCCLUSION BALLOON SYSTEM
K990487 · Micro Therapeutics, Inc. · Aug 1999
RMI NORMOCLUDER CORONARY ARTERY OCCLUDER
K915869 · Research Medical, Inc. · Dec 1992