# K101497: Delivery Sheath, Model Adelante Breezeway

- Pathway: 510(k) (Traditional)
- Applicant: Oscor, Inc.
- Decided: Oct 20, 2010 after 141 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 K964518 (1997). 18 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090114: Modification to:Introducer Sets, Model Adelante and Adelante-S, Oscor, Inc. (2009) Summary page 1.
- K072719: Convoy Advanced Delivery Sheath, Boston Scientific Corp (2008) Summary page 1.
- K081341: Reinforced Catheter Introducer System (Rcis), Thomas Medical Products, Inc. (2008) Summary page 1.
- K001139: Preface Guiding Sheath, Models 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M, Biosense Webster, Inc. (2000) Summary page 1.
- K061015: Fast-Cath Hemostasis Introducer and Transseptal Introducer, St Jude Medical (2006) Summary page 1.

## Most influential descendants
- K120459: Steerable Guiding Sheath, Model Adelante Destino (2012), 7 descendants of its own
- K151951: Destino Reach (2015), 6 descendants of its own
- K240829: AuST Steerable Sheath (2024), 5 descendants of its own
- K242106: AuST Steerable Sheath (2024), 4 descendants of its own
- K251051: AuST Steerable Sheath (2025), 3 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 to facilitate the intracardiac placement of diagnostic and therapeutic devices.

Source page: https://510kreport.com/device/K101497
Methodology: https://510kreport.com/methodology