# K210627: Breezeway II

- Pathway: 510(k) (Special)
- Applicant: Oscor, Inc.
- Decided: Jun 3, 2021 after 93 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924607 (1993). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122958: Delivery Sheath, Model Adelante Breezeway, Oscor, Inc. (2012) Summary page 4.

## Most influential descendants
- K242756: Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) (2024), 0 descendants of its own

## Indications for use
The Breezeway II products are intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

Source page: https://510kreport.com/device/K210627
Methodology: https://510kreport.com/methodology