# K965051: Heartport Needle Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Mar 12, 1997 after 84 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) Heartport Surgical Thoracic Trocar: named in the summary without a submission number
- (no number) Popper & Sons Biopsy Needle: named in the summary without a submission number

## Indications for use
The Heartport Needle Trocars are intended to provide access to the thoracic cavity. The Heartport Needle Trocar allows suture snares and similar small devices to be inserted and used during minimally invasive cardiothoracic surgery procedures.

Source page: https://510kreport.com/device/K965051
Methodology: https://510kreport.com/methodology