Cleared Traditional

K962366 - HEARTPORT CABLE BULLDOG CLAMP

K962366 is an FDA 510(k) clearance for HEARTPORT CABLE BULLDOG CLAMP, manufactured by Heartport, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K962366 · Heartport, Inc. · Cardiovascular device
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Nov 1996
Decision
141d
Days
Class 2
Risk

K962366 is an FDA 510(k) clearance for the HEARTPORT CABLE BULLDOG CLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Heartport, Inc. (Redwood City, US). The FDA issued a Cleared decision on November 7, 1996 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 - K962366

510(k) Number K962366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1996
Decision Date November 07, 1996
Days to Decision 141 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
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 180
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K962366.
MICS DEVICE SYSTEM
K963716 · Percutaneous Technologies, Inc. · Apr 1997
FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15
K964662 · Rmds, Inc. · Feb 1997
DEGANIA SILICONE INDENTI LOOPS
K964547 · Degania Silicone , Ltd. · Jan 1997
AMR-ACV CLAMPS
K962668 · Applied Medical Resources · Nov 1996
DANESHVAR WOUND SUPPORT UNIT
K955827 · Y. Daneshvar · Oct 1996
HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM
K962858 · Heartport, Inc. · Sep 1996