Cleared Traditional

K051137 - TECHDEVICE OCCLUSION BALLOON CATHETER

K051137 is an FDA 510(k) clearance for TECHDEVICE OCCLUSION BALLOON CATHETER, manufactured by Techdevice Corporation. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K051137 · Techdevice Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
296d
Days
Class 2
Risk

K051137 is an FDA 510(k) clearance for the TECHDEVICE OCCLUSION BALLOON CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Techdevice Corporation (Watertown, US). The FDA issued a Cleared decision on February 24, 2006 after a review of 296 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 Techdevice Corporation devices

FDA 510(k) Submission Details - K051137

510(k) Number K051137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2005
Decision Date February 24, 2006
Days to Decision 296 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
171d slower than avg
Panel avg: 125d · This submission: 296d
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 57
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K051137.
FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
K071367 · LeMaitre Vascular, Inc. · Aug 2007
GORE BALLOON SHEATH
K070770 · W.L. Gore & Associates, Inc. · Jun 2007
MODIFICATION TO GUARDDOG OCCLUSION SYSTEM
K062220 · Possis Medical, Inc. · Aug 2006
PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
K051067 · LeMaitre Vascular, Inc. · May 2005
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