Cleared Traditional

K052570 - TANDEMHEART TRANSSEPTAL CANNULA SET-EF

K052570 is the FDA 510(k) clearance for TANDEMHEART TRANSSEPTAL CANNULA SET-EF by Cardiacassist, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K052570 · Cardiacassist, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
120d
Days
Class 2
Risk

K052570 is an FDA 510(k) clearance for the TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on January 17, 2006 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Cardiacassist, Inc. devices

Submission Details

510(k) Number K052570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2005
Decision Date January 17, 2006
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 230
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K052570.
TENDERFLOW PERIATRIC ARTERIAL CANNULA
K063618 · Terumo Cardiovascular Systems Corp. · Mar 2007
TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA
K062597 · Terumo Cardiovascular Systems Corp. · Nov 2006
JOSTRA HLM TUBING SETS WITH SAFELINE COATING
K061832 · Maquet Cardiopulmonary, AG · Aug 2006
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
K033463 · Edwards Lifesciences, LLC · Jul 2004
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
K033464 · Edwards Lifesciences, LLC · Jun 2004
SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
K034058 · Medtronic Vascular · Jan 2004