Delivery Sheath, Model Adelante Breezeway
FDA 510(k)Class II (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K101497 FDA 510(k)
- FDA Product Code
- DYB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1340 FDA 510(k)
- Regulation Number
- 870.1340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A delivery sheath is a device intended for the percutaneous introduction of various types of cardiovascular catheters to all chambers of the heart, including transseptal puncture. It facilitates the introduction of catheters to heart chambers, including the left atrium via transseptal puncture.
The device is supplied with a three-way stopcock, hemostatic valve, and dilator. It was cleared via the FDA 510(k) pathway on October 20, 2010, under K101497, and is manufactured by Oscor Inc. in Palm Harbor, Florida.
Frequently asked questions
What is the Delivery Sheath Model Adelante Breezeway used for?
It is intended for the percutaneous introduction of various types of cardiovascular catheters to all chambers of the heart, including transseptal puncture, facilitating access to the left atrium and other cardiac chambers during interventional procedures.
What components are included with the Delivery Sheath Model Adelante Breezeway?
The device is supplied with a three-way stopcock, a hemostatic valve, and a dilator, which together support safe and controlled catheter insertion and hemostasis during use.
How was the Delivery Sheath Model Adelante Breezeway cleared for market?
It was cleared via the FDA 510(k) pathway on October 20, 2010, under submission number K101497, based on a determination of substantial equivalence to a legally marketed predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Adelante® Breezeway® Delivery Sheath - Integer, DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY by Oscor Inc. | FDA 510(k ..., delivery sheath model adelante breezeway
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101497 | Class II | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K101497 24 fields · synced Sep 22, 2026