Cleared Traditional

K011889 - ULTRA -THIN SDS BALLOON DILATATION CATHETER

K011889 is an FDA 510(k) clearance for ULTRA -THIN SDS 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 186-day FDA review.

K011889 · Boston Scientific Corp · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Dec 2001
Decision
186d
Days
Class 2
Risk

K011889 is an FDA 510(k) clearance for the ULTRA -THIN SDS BALLOON DILATATION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on December 21, 2001 after a review of 186 days - an extended review 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: 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 - K011889

510(k) Number K011889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2001
Decision Date December 21, 2001
Days to Decision 186 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
61d slower than avg
Panel avg: 125d · This submission: 186d
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 780
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K011889.
BARD CONQUEST PTA BALLOON DILATATION CATHETER
K014212 · C.R. Bard, Inc. · Jan 2002
MODIFICATION TO SUPERCROSS CATHETER
K014118 · Abbott Vascular, Inc. · Jan 2002
NUMED MULLINS PTA CATHETER
K013601 · NuMED, Inc. · Jan 2002
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
K013789 · Boston Scientific, Target · Dec 2001
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
K013638 · Guidant Corp. · Dec 2001
STENT SUPPORT GUIDE CATHETER
K010579 · Medtronic Vascular · Nov 2001