Cleared Special

K092455 - MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM

K092455 is an FDA 510(k) clearance for MODIFICATION TO: POLARCATH PERIPHERAL D..., manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 25-day FDA review.

K092455 · Boston Scientific Corporation · Cardiovascular device
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Sep 2009
Decision
25d
Days
Class 2
Risk

K092455 is an FDA 510(k) clearance for the MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on September 4, 2009 after a review of 25 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 Corporation devices

FDA 510(k) Submission Details - K092455

510(k) Number K092455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2009
Decision Date September 04, 2009
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

LIT Device Classification - Class 2, Special Controls

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 347
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