Cleared Special

K000570 - BLUE MAX BALLOON DILATATION CATHETER

K000570 is the FDA 510(k) clearance for BLUE MAX BALLOON DILATATION CATHETER by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Special 510(k) pathway after a 51-day FDA review.

K000570 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
51d
Days
Class 2
Risk

K000570 is an FDA 510(k) clearance for the BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON .... Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on April 13, 2000 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K000570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date April 13, 2000
Days to Decision 51 days
Submission Type Special
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
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 238
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K000570.
PTA BALLOON CATHETER
K001087 · Cook, Inc. · Jul 2000
TALON BALLOON DILATION CATHETER
K000798 · Boston Scientific Corp · Jun 2000
MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K992320 · Boston Scientific Corp · May 2000
TRANSLUMINAL BALLOON DILATATION CATHETER
K993305 · Boston Scientific Corp · Apr 2000
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER
K000101 · Guidant Corp. · Feb 2000
RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
K993639 · Guidant Corp. · Jan 2000