Cleared Traditional

K964302 - HEARTPORT THORACIC TROCAR

K964302 is an FDA 510(k) clearance for HEARTPORT THORACIC TROCAR, manufactured by Heartport, Inc.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K964302 · Heartport, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
192d
Days
Class 2
Risk

K964302 is an FDA 510(k) clearance for the HEARTPORT THORACIC TROCAR. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Heartport, Inc. (Redwood City, US). The FDA issued a Cleared decision on May 9, 1997 after a review of 192 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - 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 - K964302

510(k) Number K964302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1996
Decision Date May 09, 1997
Days to Decision 192 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
67d slower than avg
Panel avg: 125d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRC Device Classification - Class 2, Special Controls

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 - DRC Trocar

All 34
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K964302.
MANAN POTTS-COURNAND NEEDLE
K974742 · Medical Device Technologies, Inc. · Apr 1998
MANAN
K974743 · Medical Device Technologies, Inc. · Apr 1998
MANAN GWI GUIDE WIRE INTRODUCER
K974745 · Medical Device Technologies, Inc. · Apr 1998
HEARTPORT NEEDLE TROCAR
K965051 · Heartport, Inc. · Mar 1997
ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE
K924338 · Arrow Intl., Inc. · Mar 1993
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
K914985 · E-Z-Em, Inc. · Dec 1991