Cleared Traditional

K053118 - STERLING MONORAIL PTA BALLOON DILATATIO...

K053118 is the FDA 510(k) clearance for STERLING MONORAIL PTA BALLOON DILATATIO... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K053118 · Boston Scientific Corp · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Dec 2005
Decision
39d
Days
Class 2
Risk

K053118 is an FDA 510(k) clearance for the STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX. 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 December 16, 2005 after a review of 39 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 K053118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2005
Decision Date December 16, 2005
Days to Decision 39 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
86d faster than avg
Panel avg: 125d · This submission: 39d
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 K053118.
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