Cleared Traditional

K983270 - VOYAGER QUAD CANNULA

K983270 is an FDA 510(k) clearance for VOYAGER QUAD CANNULA, manufactured by Cardiothoracic Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K983270 · Cardiothoracic Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
314d
Days
Class 2
Risk

K983270 is an FDA 510(k) clearance for the VOYAGER QUAD CANNULA. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Cardiothoracic Systems, Inc. (Cupertino, US). The FDA issued a Cleared decision on July 28, 1999 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cardiothoracic Systems, Inc. devices

FDA 510(k) Submission Details - K983270

510(k) Number K983270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1998
Decision Date July 28, 1999
Days to Decision 314 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 125d · This submission: 314d
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 305
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K983270.
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP
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QUICKDRAW VENOUS CANNULA
K981995 · Heartport, Inc. · Apr 1999
DIRECTFLOW ARTERIAL CANNULA
K990772 · Heartport, Inc. · Mar 1999
VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE
K974259 · Edwards Lifesciences Research Medical · Dec 1998