# K964302: Heartport Thoracic Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: May 9, 1997 after 192 days
- Product code: DRC (Trocar)
- Device class: 2
- Regulation: 21 CFR 870.1390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Origin Medsystems (a Guidant Corp.) - Surgical Trocar Thoracic: named in the summary without a submission number

## Indications for use
The Heartport Thoracic Trocars are intended to provide access to the thoracic cavity by inserting them into incisions in the intercostal spaces, with minimal-to-no rib retraction. The Heartport Thoracic Trocar allows endoscopic instruments, thoracoscopes and accessory devices to be inserted and used during cardiothoracic surgery procedures.

Source page: https://510kreport.com/device/K964302
Methodology: https://510kreport.com/methodology