Cleared Traditional

K000798 - TALON BALLOON DILATION CATHETER

K000798 is the FDA 510(k) clearance for TALON BALLOON DILATION 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.

K000798 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
87d
Days
Class 2
Risk

K000798 is an FDA 510(k) clearance for the TALON BALLOON DILATION 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 June 8, 2000 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 K000798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date June 08, 2000
Days to Decision 87 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
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 K000798.
TYSHAK, MODEL 102 AND Z-MED, MODEL 302
K991977 · NuMED, Inc. · Sep 2000
GAZELLE BALLOON DILATATION CATHETER
K001134 · Boston Scientific Corp · Aug 2000
PTA BALLOON CATHETER
K001087 · Cook, Inc. · Jul 2000
MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K992320 · Boston Scientific Corp · May 2000
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA
K000570 · Boston Scientific Corp · Apr 2000
TRANSLUMINAL BALLOON DILATATION CATHETER
K993305 · Boston Scientific Corp · Apr 2000