Cleared Traditional

K003320 - PTA-OS SIZING BALLOON

K003320 is the FDA 510(k) clearance for PTA-OS SIZING BALLOON by NuMED, Inc.. It is a Class 2 Cardiovascular device (product code MJN) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K003320 · NuMED, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
190d
Days
Class 2
Risk

K003320 is an FDA 510(k) clearance for the PTA-OS SIZING BALLOON, MODEL 360. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on May 2, 2001 after a review of 190 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 NuMED, Inc. devices

Submission Details

510(k) Number K003320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2000
Decision Date May 02, 2001
Days to Decision 190 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
65d slower than avg
Panel avg: 125d · This submission: 190d
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 45
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K003320.
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
K011656 · Micro Therapeutics, Inc. · Jun 2001
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123
K011526 · Micro Therapeutics, Inc. · Jun 2001
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
K010162 · Micro Therapeutics, 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