# K122958: Delivery Sheath, Model Adelante Breezeway

- Pathway: 510(k) (Traditional)
- Applicant: Oscor, Inc.
- Decided: Dec 13, 2012 after 79 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 30 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924607 (1993). 7 ancestors in all.
2 later devices descend 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)
- K081341: Reinforced Catheter Introducer System (Rcis), Thomas Medical Products, Inc. (2008) Summary page 1.
- K081045: Destination Renal Guiding Sheath, Terumo Medical Corp. (2008) Summary page 1.
- K970229: Arrow Transseptal Super Arrow-Flex Percutaneous Set, Arrow Intl., Inc. (1998) Summary page 1.

## Most influential descendants
- K210627: Breezeway II (2021), 1 descendant of its own
- 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

## Recalls of this device
- Oct 5, 2016 · Class II · Z-0796-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0798-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0800-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0805-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0806-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0810-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0792-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0793-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0795-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0797-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0799-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0803-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0790-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0791-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0794-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0802-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0804-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0811-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0812-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0813-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0814-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0816-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0818-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0801-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0807-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0808-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0809-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0815-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0817-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Oct 5, 2016 · Class II · Z-0819-2017: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.

## Indications for use
The Adelante® Breezeway Delivery Sheath is 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/K122958
Methodology: https://510kreport.com/methodology