Cleared Traditional

K143561 - ELM PTA Balloon Dilatation Catheter

K143561 is an FDA 510(k) clearance for ELM PTA Balloon Dilatation Catheter, manufactured by O'Connell Regulatory Consultants, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K143561 · O'Connell Regulatory Consultants, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
154d
Days
Class 2
Risk

K143561 is an FDA 510(k) clearance for the ELM PTA Balloon Dilatation Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by O'Connell Regulatory Consultants, Inc. (North Reading, US). The FDA issued a Cleared decision on May 19, 2015 after a review of 154 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.

FDA 510(k) Submission Details - K143561

510(k) Number K143561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2014
Decision Date May 19, 2015
Days to Decision 154 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 382
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K143561.
XXL Vascular Balloon Dilatation Catheter
K150303 · Boston Scientific Corp · Jun 2015
Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter
K143041 · Natec Medical , Ltd. · Jun 2015
PTA 14 Balloon Dilatation Catheter OTW
K142954 · Texasmedical Technologies, Inc. · May 2015
FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm
K150946 · Ostial Corporation · May 2015
Ebony PTA 0.035 Peripheral Dilatation Catheter
K143036 · Natec Medical , Ltd. · Mar 2015
Vector PTA Balloon Dilatation Catheter
K143652 · Vector Corporation, LLC · Feb 2015
K143561 · ELM PTA Balloon Dilatation Catheter
Download PDF FDA Summary O'Connell Regulatory …