Cleared Traditional

K993248 - AMPLATZER SIZING BALLOON

K993248 is an FDA 510(k) clearance for AMPLATZER SIZING BALLOON, manufactured by Aga Medical Corp.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K993248 · Aga Medical Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2000
Decision
288d
Days
Class 2
Risk

K993248 is an FDA 510(k) clearance for the AMPLATZER SIZING BALLOON. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Aga Medical Corp. (Plymouth, US). The FDA issued a Cleared decision on July 12, 2000 after a review of 288 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 Aga Medical Corp. devices

FDA 510(k) Submission Details - K993248

510(k) Number K993248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1999
Decision Date July 12, 2000
Days to Decision 288 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
163d slower than avg
Panel avg: 125d · This submission: 288d
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 62
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K993248.
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
BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER
K993292 · Boston Scientific, Target · Mar 2000
EQUINOX OCCLUSION BALLOON SYSTEM
K990487 · Micro Therapeutics, Inc. · Aug 1999