Cleared Traditional

K962510 - HEARTPORT ENDOAORTIC CLAMP

K962510 is an FDA 510(k) clearance for HEARTPORT ENDOAORTIC 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 76-day FDA review.

K962510 · Heartport, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
76d
Days
Class 2
Risk

K962510 is an FDA 510(k) clearance for the HEARTPORT ENDOAORTIC 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 September 11, 1996 after a review of 76 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Heartport, Inc. devices

FDA 510(k) Submission Details - K962510

510(k) Number K962510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1996
Decision Date September 11, 1996
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
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 84
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K962510.
HEARTPORT CABLE BULLDOG CLAMP
K962366 · Heartport, Inc. · Nov 1996
AMR-ACV CLAMPS
K962668 · Applied Medical Resources · Nov 1996
HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM
K962858 · Heartport, Inc. · Sep 1996
HEARTPORT ENDOAORTIC CLAMP
K955132 · Heartport, Inc. · Jun 1996
FEMOSTOP, FEMOSTOP PUMP
K954669 · Radi Medical Systems AB · Oct 1995
FOGARTY-HYDRAGRIP SURGICAL CLAMPS
K951413 · Baxter Healthcare Corp · Aug 1995