Cleared Traditional

HEARTPORT NEEDLE TROCAR (K965051) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K965051 · Heartport, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
84d
Days
Class 2
Risk

K965051 is an FDA 510(k) clearance for the HEARTPORT NEEDLE 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 March 12, 1997 after a review of 84 days - a notably fast clearance 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: 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

Submission Details

510(k) Number K965051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1996
Decision Date March 12, 1997
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K965051.
TSN Transseptal Needle
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AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT
K893707 · United States Surgical, A Division of Tyco Healthc · Jun 1989
DILUTION KIT, THERMAL, COLD PAC
K781221 · Instrumentation Laboratory CO · Aug 1978
ADVANSET
K771261 · C.R. Bard, Inc. · Aug 1977