Cleared Traditional

K111284 - FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K111284 · Ostial Corporation · Cardiovascular device
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Aug 2011
Decision
103d
Days
Class 2
Risk

K111284 is an FDA 510(k) clearance for the FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Ostial Corporation (Mountain View, US). The FDA issued a Cleared decision on August 17, 2011 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - 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 Ostial Corporation devices

Submission Details

510(k) Number K111284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2011
Decision Date August 17, 2011
Days to Decision 103 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 125d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.
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 - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 85
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K111284.
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