Fortress Introducer Sheath System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Fortress Introducer Sheath System EUDAMEDBiotronik Fortress Introducer Sheath System FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Fortress Introducer Sheath System EUDAMEDIntroducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. FDA UDI
- Model / Reference
- 452388 EUDAMED7F; 90 cm; straight FDA UDI
- Description
- Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. FDA UDI
Identifiers
- Catalog Number
- 452388 FDA UDI
- Primary DI / UDI-DI
- 04251244503796 EUDAMEDFDA UDI
- Basic UDI-DI
- 4251244500000113F EUDAMED
- FDA Product Code
- DYB FDA UDIDRE FDA UDI
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 FDA UDI870.1310 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 90 Centimeter FDA UDILumen/Inner Diameter — 2.55 Millimeter FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Fortress Introducer Sheath System by Contract Medical International GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Similar devices
Also classified as Vascular catheter introduction set, nonimplantable.
- VYGON — Vygon Corp. · Class II
- OneStic Micro-Access Introducer — Argon Medical Devices, Inc. · Class II
- Prelude EASE™ — Merit Medical Systems, Inc. · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153197 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K203179 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4251244500000113F | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Contract Medical International GmbH
- EUDAMED SRN
- DE-MF-000007409
- FDA Applicant
- Contract Medical International, GmbH
Sources (3)
- EUDAMED 88fbd91f-e260-4827-80b6-182405e6a7ea 85 fields · synced Jun 19, 2026
- FDA UDI f2a80bfa-560b-4a01-a79d-42999558d75e 37 fields · synced May 30, 2026
- FDA 510(k) K153197 1 fields · synced May 18, 2026