Cleared Traditional

K050389 - ULTRA-SOFT SV BALLOON DILATATION CATHETER

K050389 is the FDA 510(k) clearance for ULTRA-SOFT SV BALLOON DILATATION CATHETER by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K050389 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
99d
Days
Class 2
Risk

K050389 is an FDA 510(k) clearance for the ULTRA-SOFT SV BALLOON DILATATION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on May 25, 2005 after a review of 99 days - within the typical 510(k) review window.

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: 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 Boston Scientific Corp devices

Submission Details

510(k) Number K050389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2005
Decision Date May 25, 2005
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
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 - DQY Catheter, Percutaneous

All 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K050389.
MINI GHOST PTA CATHETER, MODEL 507
K051343 · NuMED, Inc. · Jul 2005
TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER
K050599 · Boston Scientific Corp · Jun 2005
ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
K051060 · AngioDynamics, Inc. · May 2005
6F Z4 GUIDE CATHETER
K042489 · Medtronic Vascular · Dec 2004
EXCELSIOR 1018 AND SL-10 MICROCATHETERS
K042568 · Boston Scientific Corp · Oct 2004
ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY
K042194 · Medtronic Vascular · Sep 2004