Cleared Special

K091119 - MODIFICATION TO THE CROSSER SYSTEM

K091119 is an FDA 510(k) clearance for MODIFICATION TO THE CROSSER SYSTEM, manufactured by Flowcardia, Inc.. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Special 510(k) pathway after a 28-day FDA review.

K091119 · Flowcardia, Inc. · Cardiovascular device
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May 2009
Decision
28d
Days
Class 2
Risk

K091119 is an FDA 510(k) clearance for the MODIFICATION TO THE CROSSER SYSTEM. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Flowcardia, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 15, 2009 after a review of 28 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 Flowcardia, Inc. devices

FDA 510(k) Submission Details - K091119

510(k) Number K091119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2009
Decision Date May 15, 2009
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

PDU Device Classification - Class 2, Special Controls

Product Code PDU Catheter For Crossing Total Occlusions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement.
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 - PDU Catheter For Crossing Total Occlusions

All 43
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K091119.
WILDCAT CATHETER
K111338 · Avinger, Inc. · Aug 2011
POWERWIRE RADIOFREQUENCY GUIDEWIRE
K101615 · Baylis Medical Co., Inc. · Jul 2010
PIONEER PLUS CATHETER, MODEL PLUS 120
K101777 · Medtronic Vascular · Jul 2010
MICRO GUIDE CATHETER XP
K082143 · Cordis Corp. · Aug 2008
PIONEER PLUS CATHETER
K081804 · Medtronic, Inc. · Aug 2008
PIONEER CATHETER
K072155 · Medtronic, Inc. · Oct 2007