Cleared Special

K062275 - RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135

K062275 is an FDA 510(k) clearance for RINSPIRATION CATHETER SYSTEM, manufactured by Kerberos Proximal Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Special 510(k) pathway after a 44-day FDA review.

K062275 · Kerberos Proximal Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
44d
Days
Class 2
Risk

K062275 is an FDA 510(k) clearance for the RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by Kerberos Proximal Solutions, Inc. (Cupertino, US). The FDA issued a Cleared decision on September 20, 2006 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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.

FDA 510(k) Submission Details - K062275

510(k) Number K062275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 07, 2006
Decision Date September 20, 2006
Days to Decision 44 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
81d faster than avg
Panel avg: 125d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

QEZ Device Classification - Class 2, Special Controls

Product Code QEZ Aspiration Thrombectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.
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 - QEZ Aspiration Thrombectomy Catheter

All 94
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K062275.
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K053372 · Lumen Biomedical, Inc. · Jun 2006
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K062275 · RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135
Download PDF FDA Summary Kerberos Proximal Sol…