Identity
- Trade Name
- RelayPro Thoracic Stent-Graft System FDA UDI
- Generic Name
- Descending thoracic aorta endovascular stent-graft FDA UDI
- Device Name
- Endovascular Stent-Graft System FDA UDI
- Model / Reference
- 28-M4-28-210-38U FDA UDI
- Description
- Endovascular Stent-Graft System FDA UDI
Identifiers
- Catalog Number
- 28-M4-28-210-38U FDA UDI
- Primary DI / UDI-DI
- 00843576155916 FDA UDI
- PMA Number
- P200045 FDA UDI
- FDA Product Code
- MIH FDA UDI
- GMDN Term
- Descending thoracic aorta endovascular stent-graft FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 28 Millimeter FDA UDIOuter Diameter — 38 Millimeter FDA UDILength — 223 Millimeter FDA UDICatheter Gauge — 21 French FDA UDI
Category: Descending thoracic aorta endovascular stent-graft
A comprehensive guide to the RelayPro Thoracic Stent-Graft System, a cutting-edge medical device designed for percutaneous implantation in the descending thoracic aorta. Learn about its features, regulatory compliance, and use cases.
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Also classified as Descending thoracic aorta endovascular stent-graft.
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- VALIANT® Captivia — MEDTRONIC, INC. · Class III
- CP Stent™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class III
- VALIANT® Captivia — MEDTRONIC, INC. · Class III
- GORE TAG Conformable Thoracic Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class III
- VALIANT® Captivia — MEDTRONIC, INC. · Class III
Cleared under the same submission
P200045 also covers:
- RelayPro NBS Thoracic Stent-Graft System — Bolton Medical Inc.
- RelayPro NBS Thoracic Stent-Graft System — Bolton Medical Inc.
- RelayPro NBS Thoracic Stent-Graft System — Bolton Medical Inc.
- RelayPro NBS Thoracic Stent-Graft System — Bolton Medical Inc.
- RelayPro NBS Thoracic Stent-Graft System — Bolton Medical Inc.
- RelayPro Thoracic Stent-Graft System — Bolton Medical Inc.
- RelayPro Thoracic Stent-Graft System — Bolton Medical Inc.
- RelayPro Thoracic Stent-Graft System — Bolton Medical Inc.
- RelayPro Thoracic Stent-Graft System — Bolton Medical Inc.
- RelayPro Thoracic Stent-Graft System — Bolton Medical Inc.
- RelayPro Thoracic Stent-Graft System — Bolton Medical Inc.
- RelayPro Thoracic Stent-Graft System — Bolton Medical Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Bolton Medical Inc.
Sources (1)
- FDA UDI d5a3da8f-22c9-4239-8419-917a0d11ac8a 37 fields · synced Oct 7, 2026