Cleared Traditional

K964248 - HEARTPORT ENDOCORONARY SINUS CATHETR

K964248 is an FDA 510(k) clearance for HEARTPORT ENDOCORONARY SINUS CATHETR, 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 90-day FDA review.

K964248 · Heartport, Inc. · Cardiovascular device
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Jan 1997
Decision
90d
Days
Class 2
Risk

K964248 is an FDA 510(k) clearance for the HEARTPORT ENDOCORONARY SINUS CATHETR. 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 January 22, 1997 after a review of 90 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K964248

510(k) Number K964248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1996
Decision Date January 22, 1997
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 K964248.
CAHSE AORTIC ROOT CANNULA
K964198 · Chase Medical, Inc. · Mar 1997
CHASE CORONARY SINUS PERFUSION CANNULA
K964199 · Chase Medical, Inc. · Mar 1997
HEARTPORT ENDOVENOUS DRAINAGE CANNULA
K962835 · Heartport, Inc. · Feb 1997
RMI HEMOCONCENTRACTOR TUBING SET
K961927 · Research Medical, Inc. · Aug 1996
HEARTPORT ENDOPULMONARY VENT
K961245 · Heartport, Inc. · Jun 1996
HEARTPORT ENDOSINUS CATHETER
K961270 · Heartport, Inc. · Jun 1996