Cleared Traditional

K052570 - TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221

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

K052570 · Cardiacassist, Inc. · Cardiovascular device
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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

FDA 510(k) Submission Details - K052570

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
Combination Product No
PCCP Authorized No
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.

DWF Device Classification - Class 2, Special Controls

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 330
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K052570.
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
EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222
K061254 · Medtronic Perfusion Systems · Jun 2006
REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA
K052081 · Estech, Inc. · Dec 2005
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
K052524 · Medtronic Perfusion Systems · Nov 2005
MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C
K052372 · Medtronic Perfusion Systems · Sep 2005