Cleared Special

K133293 - 15 FR. TANDEMHEART ARTERIAL CANNULA

K133293 is an FDA 510(k) clearance for 15 FR. TANDEMHEART ARTERIAL CANNULA, manufactured by Cardiacassist, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Special 510(k) pathway after a 110-day FDA review.

K133293 · Cardiacassist, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
110d
Days
Class 2
Risk

K133293 is an FDA 510(k) clearance for the 15 FR. TANDEMHEART ARTERIAL CANNULA. 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 February 12, 2014 after a review of 110 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133293

510(k) Number K133293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date February 12, 2014
Days to Decision 110 days
Submission Type Special
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
15d faster than avg
Panel avg: 125d · This submission: 110d
Pathway characteristics
Modification to existing cleared device.

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 403
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K133293.
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
K140208 · Edwards Lifesciences, LLC · Mar 2014
SARNS SOFT-FLOW EXTENDED AORTIC CANNULA
K132811 · Terumo Cardiovascular Systems Corporation · Feb 2014
SARNS SOFT-FLOW AORTIC CANNULA
K132451 · Terumo Cardiovascular Systems Corp. · Feb 2014
SARNS HIGH FLOW AORTIC ARCH CANNULA
K133151 · Terumo Cardiovascular Systems Corp. · Feb 2014
TANDEMHEART FEMORAL VENOUS CANNULA SET
K133236 · Cardiacassist, Inc. · Jan 2014
DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO
K132995 · Medtronic, Inc. · Oct 2013
K133293 · 15 FR. TANDEMHEART ARTERIAL CANNULA
Download PDF FDA Summary Cardiacassist, Inc.