Cleared Special

DIRECTFLOW ARTERIAL CANNULA (K990772) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K990772 · Heartport, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
14d
Days
Class 2
Risk

K990772 is an FDA 510(k) clearance for the DIRECTFLOW ARTERIAL CANNULA. 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 March 23, 1999 after a review of 14 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 Heartport, Inc. devices

Submission Details

510(k) Number K990772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1999
Decision Date March 23, 1999
Days to Decision 14 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 K990772.
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