Cleared Special

K083301 - X-COATED TERUMO AND SARNS DUAL STAGE VE...

K083301 is an FDA 510(k) clearance for X-COATED TERUMO AND SARNS DUAL STAGE VE..., 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 38-day FDA review.

K083301 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
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Dec 2008
Decision
38d
Days
Class 2
Risk

K083301 is an FDA 510(k) clearance for the X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE.... 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 December 18, 2008 after a review of 38 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 - K083301

510(k) Number K083301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2008
Decision Date December 18, 2008
Days to Decision 38 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
87d faster than avg
Panel avg: 125d · This submission: 38d
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 K083301.
MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)
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