# K972570: Heartport Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Heartport, Inc.
- Decided: Oct 1, 1997 after 83 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 5 (0 Class I)
- 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® Endoarterial Return™ Cannula: named in the summary without a submission number

## Recalls of this device
- Oct 2, 2003 · Not classified · Z-0308-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0310-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0307-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0309-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0311-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.

## Indications for use
The Introducer Sheath with hemostasis valve is indicated for patients requiring introduction of catheters. It is intended for the hemostatic introduction and removal of vascular catheters such as the Heartport® Endoaortic Clamp™ Catheter.

Source page: https://510kreport.com/device/K972570
Methodology: https://510kreport.com/methodology