Cleared Traditional

K981995 - QUICKDRAW VENOUS CANNULA

K981995 is an FDA 510(k) clearance for QUICKDRAW VENOUS CANNULA, manufactured by Heartport, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K981995 · Heartport, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 1999
Decision
316d
Days
Class 2
Risk

K981995 is an FDA 510(k) clearance for the QUICKDRAW VENOUS 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 April 20, 1999 after a review of 316 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 Heartport, Inc. devices

FDA 510(k) Submission Details - K981995

510(k) Number K981995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1998
Decision Date April 20, 1999
Days to Decision 316 days
Submission Type Traditional
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
191d slower than avg
Panel avg: 125d · This submission: 316d
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 283
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K981995.
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP
K994243 · Heartport, Inc. · May 2000
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT
K993677 · Medtronic Vascular · Apr 2000
MADTRONIC DLP ARTERIAL CANNULAE
K991066 · Medtronic Vascular · Sep 1999
DIRECTFLOW ARTERIAL CANNULA
K990772 · Heartport, Inc. · Mar 1999
HEARTPORT ENDOPULMONARY VENT CATHETER
K981009 · Heartport, Inc. · Sep 1998
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
K981601 · Sorin Group Italia S.R.L. · Jul 1998