Cleared Special

K990772 - DIRECTFLOW ARTERIAL CANNULA

K990772 is an FDA 510(k) clearance for DIRECTFLOW ARTERIAL CANNULA, manufactured by Heartport, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Special 510(k) pathway after a 14-day FDA review.

K990772 · Heartport, Inc. · Cardiovascular device
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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

FDA 510(k) Submission Details - K990772

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
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 K990772.
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K981009 · Heartport, Inc. · Sep 1998
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
K981601 · Sorin Group Italia S.R.L. · Jul 1998
HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER
K974736 · Heartport, Inc. · Jul 1998