Cleared Traditional

K133236 - TANDEMHEART FEMORAL VENOUS CANNULA SET

K133236 is an FDA 510(k) clearance for TANDEMHEART FEMORAL VENOUS CANNULA SET, 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 100-day FDA review.

K133236 · Cardiacassist, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
100d
Days
Class 2
Risk

K133236 is an FDA 510(k) clearance for the TANDEMHEART FEMORAL VENOUS CANNULA SET. 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 29, 2014 after a review of 100 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 - K133236

510(k) Number K133236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2013
Decision Date January 29, 2014
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
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 329
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K133236.
SARNS SOFT-FLOW AORTIC CANNULA
K132451 · Terumo Cardiovascular Systems Corp. · Feb 2014
15 FR. TANDEMHEART ARTERIAL CANNULA
K133293 · Cardiacassist, Inc. · Feb 2014
SARNS HIGH FLOW AORTIC ARCH CANNULA
K133151 · Terumo Cardiovascular Systems Corp. · Feb 2014
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO
K132995 · Medtronic, Inc. · Oct 2013
DLP CORONARY OSTIAL PERFUSION CANNULAE
K131269 · Medtronic, Inc. · Jul 2013
ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
K131666 · Maquet Cardiopulmonary, AG · Jul 2013