Cleared Traditional

K050389 - ULTRA-SOFT SV BALLOON DILATATION CATHETER

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

K050389 · Boston Scientific Corp · Cardiovascular device
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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

FDA 510(k) Submission Details - K050389

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.

DQY Device Classification - Class 2, Special Controls

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 779
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
ENPATH DEFLECTABLE CATHETER
K043489 · Enpath Medical Incorporated · May 2005
RELIANT STENT GRAFT BALLOON CATHETER
K050038 · Medtronic Endovascular Innovations · Apr 2005
ALLIGATOR RETRIEVAL DEVICE (ARD)
K043580 · Chestnut Medical Technologies, Inc. · Mar 2005