Cleared Special

K062597 - TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA

K062597 is an FDA 510(k) clearance for TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA, manufactured by Terumo Cardiovascular Systems Corp.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Special 510(k) pathway after a 63-day FDA review.

K062597 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
63d
Days
Class 2
Risk

K062597 is an FDA 510(k) clearance for the TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corp. (Ann Arbor, US). The FDA issued a Cleared decision on November 3, 2006 after a review of 63 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Terumo Cardiovascular Systems Corp. devices

FDA 510(k) Submission Details - K062597

510(k) Number K062597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2006
Decision Date November 03, 2006
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
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 283
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K062597.
THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
K080034 · Terumo Cardiovascular Systems Corp. · Jun 2008
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K072172 · Maquet Cardiopulmonary, AG · Aug 2007
TENDERFLOW PERIATRIC ARTERIAL CANNULA
K063618 · Terumo Cardiovascular Systems Corp. · Mar 2007
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
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
K052524 · Medtronic Perfusion Systems · Nov 2005