Cleared Traditional

K994141 - CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510

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

K994141 is an FDA 510(k) clearance for CATHETER, manufactured by Medtronic Ave, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K994141

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
Combination Product No
PCCP Authorized No
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.

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 79
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
AMPLATZER SIZING BALLOON
K993248 · Aga Medical Corp. · Jul 2000
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
LEMAITRE OCCLUSION CATHETER
K992942 · Vascutech, Inc. · Apr 2000