Cleared Special

K093636 - STERLING ES MONORAIL AND OVER-THE-WIRE ...

K093636 is the FDA 510(k) clearance for STERLING ES MONORAIL AND OVER-THE-WIRE ... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Special 510(k) pathway after a 29-day FDA review.

K093636 · Boston Scientific Corp · Cardiovascular device
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Dec 2009
Decision
29d
Days
Class 2
Risk

K093636 is an FDA 510(k) clearance for the STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL.... Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on December 23, 2009 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K093636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2009
Decision Date December 23, 2009
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 226
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K093636.
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K093970 · Penumbra, Inc. · Jan 2010
STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO
K093720 · Boston Scientific Corp · Dec 2009
MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM
K092455 · Boston Scientific Corporation · Sep 2009
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS
K080982 · Boston Scientific Corp · Jul 2008