Cleared Traditional

HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER (K974736) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K974736 · Heartport, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
208d
Days
Class 2
Risk

K974736 is an FDA 510(k) clearance for the HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Heartport, Inc. (Redwood City, US). The FDA issued a Cleared decision on July 15, 1998 after a review of 208 days - an extended review cycle.

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. Standard predicate reliance. 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 Heartport, Inc. devices

Submission Details

510(k) Number K974736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1997
Decision Date July 15, 1998
Days to Decision 208 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
83d slower than avg
Panel avg: 125d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 105
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K974736.
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
K012538 · Medtronic Vascular · Aug 2001
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT
K993677 · Medtronic Vascular · Apr 2000
MADTRONIC DLP ARTERIAL CANNULAE
K991066 · Medtronic Vascular · Sep 1999
EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM
K932208 · Baxter Healthcare Corp · Aug 1994
BARD WILLIAM HARVEY TWO STAGE CANNULA
K930684 · C.R. Bard, Inc. · May 1993
BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA
K930620 · C.R. Bard, Inc. · May 1993