Cleared Traditional

K071309 - BLUE MAX BALLOON DILATATION CATHETER

K071309 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 Traditional 510(k) pathway after a 65-day FDA review.

K071309 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
65d
Days
Class 2
Risk

K071309 is an FDA 510(k) clearance for the BLUE MAX BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on July 13, 2007 after a review of 65 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K071309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2007
Decision Date July 13, 2007
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K071309.
VACCESS PTA BALLOON DILATATION CATHETER
K073472 · C.R. Bard, Inc. · Jan 2008
PASSEO 18
K072765 · Biotronik, Inc. · Dec 2007
FOX SV PTA CATHETER
K072824 · Abbott Laboratories · Oct 2007
POLARCATH PERIPHERAL DILATATION SYSTEM
K071042 · Boston Scientific Corp · Jun 2007
FOX SV PTA CATHETER
K062843 · Abbott Laboratories · Oct 2006
SYMMETRY BALLOON DILATATION CATHETER
K060959 · Boston Scientific Corporation · Apr 2006