Cleared Traditional

K011889 - ULTRA -THIN SDS BALLOON DILATATION CATH...

K011889 is the FDA 510(k) clearance for ULTRA -THIN SDS BALLOON DILATATION CATH... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (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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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

Submission Details

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.

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 K011889.
6F MACH1/34356-XXX
K020028 · Boston Scientific · Jan 2002
BARD CONQUEST PTA BALLOON DILATATION CATHETER
K014212 · C.R. Bard, Inc. · Jan 2002
NUMED MULLINS PTA CATHETER
K013601 · NuMED, Inc. · Jan 2002
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
K013638 · Guidant Corp. · Dec 2001
STENT SUPPORT GUIDE CATHETER
K010579 · Medtronic Vascular · Nov 2001
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
K010954 · Concentric Medical, Inc. · Oct 2001