Cleared Traditional

K052844 - KAVS - CATHETER, MODELS 1107100 & 1107060

K052844 is an FDA 510(k) clearance for KAVS - CATHETER, manufactured by Richter & Rothe AG. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K052844 · Richter & Rothe AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
164d
Days
Class 2
Risk

K052844 is an FDA 510(k) clearance for the KAVS - CATHETER, MODELS 1107100 & 1107060. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Richter & Rothe AG (Leipzig, DE). The FDA issued a Cleared decision on March 20, 2006 after a review of 164 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Richter & Rothe AG devices

FDA 510(k) Submission Details - K052844

510(k) Number K052844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2005
Decision Date March 20, 2006
Days to Decision 164 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
39d slower than avg
Panel avg: 125d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJN Device Classification - Class 2, Special Controls

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - MJN Catheter, Intravascular Occluding, Temporary

All 73
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K052844.
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PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49
K043023 · LeMaitre Vascular, Inc. · Dec 2004
NUMED PTS X SIZING BALLOON CATHETER
K041306 · NuMED, Inc. · Jun 2004