Cleared Traditional

K970379 - CHANNEL BALLOON CATHETER

K970379 is the FDA 510(k) clearance for CHANNEL BALLOON CATHETER by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K970379 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
87d
Days
Class 2
Risk

K970379 is an FDA 510(k) clearance for the CHANNEL BALLOON CATHETER. 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 May 1, 1997 after a review of 87 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 K970379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date May 01, 1997
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 K970379.
PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS
K971010 · Cordis Corp. · Jun 1997
MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
K953647 · Meadox Medicals, Div. Boston Scientific Corp. · May 1997
CORDIS OPTA5 PTA BALLOON CATHETER
K970620 · Cordis Corp. · May 1997
VANTAGE PERIPHERAL DILATATION CATHETER
K965183 · Guidant Corp. · Apr 1997
JUPITER PTA CATHETERS (VARIOUS)
K970299 · Cordis Corp. · Apr 1997
MAXI LD PTA BALLOON CATHETER
K963000 · Cordis Corp. · Feb 1997