Cleared Traditional

K102418 - REVERSE MEDICAL REPORT GUIDE CATHETER S...

K102418 is an FDA 510(k) clearance for REVERSE MEDICAL REPORT GUIDE CATHETER S..., manufactured by Reverse Medical Corporation. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K102418 · Reverse Medical Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
233d
Days
Class 2
Risk

K102418 is an FDA 510(k) clearance for the REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Reverse Medical Corporation (Irvine, US). The FDA issued a Cleared decision on April 15, 2011 after a review of 233 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Reverse Medical Corporation devices

FDA 510(k) Submission Details - K102418

510(k) Number K102418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2010
Decision Date April 15, 2011
Days to Decision 233 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 125d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
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 - DQY Catheter, Percutaneous

All 652
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K102418.
SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
K111154 · Biotronik, Inc. · May 2011
TERUMO SUPPORT CATHETER
K110540 · Terumo Medical Corp. · May 2011
SELECTRA CS LEAD INTRODUCER SYSTEM
K110461 · Biotronik, Inc. · Apr 2011
MODIFIED HD GUIDE CATHETER
K110483 · Concentric Medical, Inc. · Apr 2011
MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS
K103386 · Medtronic, Inc. · Feb 2011
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
K101659 · Vascular Solutions, Inc. · Dec 2010