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
- 386591 EUDAMED5F; 45 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
- 386591 FDA UDI
- Primary DI / UDI-DI
- 04251244503659 EUDAMEDFDA UDI
- Basic UDI-DI
- 4251244500000113F EUDAMED
- 510(k) Number
- K153197 FDA UDI
- 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 — 45 Centimeter FDA UDILumen/Inner Diameter — 1.95 Millimeter FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Fortress Introducer Sheath System by Contract Medical International GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4251244500000113F | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Contract Medical International GmbH
- EUDAMED SRN
- DE-MF-000007409
Sources (2)
- EUDAMED b9c32a0d-3ad5-4bb0-9bc9-ee312e5d2a40 61 fields · synced Jun 8, 2026
- FDA UDI a09abb80-7f4d-4b6c-b669-60c32aeae16e 38 fields · synced May 30, 2026