Amplatzer Steerable Delivery Sheath
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220340 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Amplatzer Steerable Delivery Sheath is a cardiovascular device designed to provide distal bidirectional steerability for the delivery of the Amplatzer Amulet Left Atrial Appendage Occluder during cardiac procedures. It is used to assist in the implantation of the occluder to help reduce the risk of stroke in patients with atrial fibrillation.
The device is supplied by Abbott Medical and was cleared through the FDA 510(k) pathway under k-number K220340 with product code DQY. It is classified as a Class 2 device and is intended for use in cardiovascular procedures as part of a system for left atrial appendage occlusion.
Frequently asked questions
What is the Amplatzer Steerable Delivery Sheath used for?
The Amplatzer Steerable Delivery Sheath is designed to provide distal bidirectional steerability to assist in the delivery of the Amplatzer Amulet Left Atrial Appendage Occluder during cardiac procedures. It helps position the occluder accurately to reduce stroke risk in patients with atrial fibrillation by enabling precise navigation within the left atrial appendage.
How is the Amplatzer Steerable Delivery Sheath supplied and is it reusable?
The device is supplied sterile by Abbott Medical and is intended for single-use only. It should not be reprocessed or reused, as doing so may compromise sterility, functionality, and patient safety. Single-use design ensures consistent performance and reduces infection risk.
What regulatory pathway was used for the Amplatzer Steerable Delivery Sheath?
The Amplatzer Steerable Delivery Sheath was cleared through the FDA 510(k) pathway under k-number K220340. It was found substantially equivalent to a predicate device and is classified as a Class 2 medical device with product code DQY, indicating its regulatory classification for cardiovascular delivery systems.
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: Amplatzer Steerable Delivery Sheath Recall and Injury Risks, First-in-Human Experience With the Amplatzer Steerable Delivery Sheath ..., Amplatzer Steerable Delivery Sheath - Abbott Medical | FDA Evidence Review
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220340 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA 510(k) K220340 24 fields · synced Sep 21, 2026