# K070770: Gore Balloon Sheath

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Jun 29, 2007 after 101 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003085 (2001). 3 ancestors in all.
6 later devices descend from it; 1 cites it directly.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001917: Parodi Catheter for Angiography (Parca), Arteria Medical Science, Inc. (2001) Summary page 2.
- K002286: Ldob Occlusion Balloon Catheter, Cook, Inc. (2001) Summary page 2.
- K003085: Concentric Guide Catheter, Models 90018, 90020, Concentric Medical, Inc. (2001) Summary page 2.

## Most influential descendants
- K083300: Gore Flow Reversal System (2009), 5 descendants of its own
- K143072: ENROUTE Transcarotid Neuroprotection System (2015), 2 descendants of its own
- K153485: ENROUTE Transcarotid Neuroprotection System (2016), 1 descendant of its own
- K230402: ENROUTE® Transcarotid Neuroprotection System (2023), 0 descendants of its own
- K123156: Gore Flow Reversal System Model GFRS073 (2012), 0 descendants of its own

## Indications for use
The GORE Balloon Sheath is indicated for temporary occlusion, selective angiography, and/or facilitating the introduction and placement of intravascular devices into selected blood vessels in the peripheral and neurovascular systems.

Source page: https://510kreport.com/device/K070770
Methodology: https://510kreport.com/methodology