Cleared Special

K090878 - MODIFICATION TO TERUMO'S TENDERFLOW PED...

K090878 is an FDA 510(k) clearance for MODIFICATION TO TERUMO'S TENDERFLOW PED..., 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 3-day FDA review.

K090878 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
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Apr 2009
Decision
3d
Days
Class 2
Risk

K090878 is an FDA 510(k) clearance for the MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING). 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 April 3, 2009 after a review of 3 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 - K090878

510(k) Number K090878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2009
Decision Date April 03, 2009
Days to Decision 3 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 125d · This submission: 3d
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 K090878.
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