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TightRail Mini Rotating Dilator Sheath
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref 540-009510(k) K142546
Identity
- Trade Name
- TightRail Mini Rotating Dilator Sheath EUDAMEDFDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Device Name
- TightRail Mini Rotating Dilator Sheath EUDAMED
- Model / Reference
- 540-009 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 540-009 FDA UDI
- Primary DI / UDI-DI
- 00813132021610 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132021610 EUDAMED
- FDA Product Code
- DRE FDA UDI
- EMDN Code
- C9002 VASCULAR AND FASCIAL DILATORS EUDAMED
- GMDN Term
- Vascular dilator, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1310 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 0.119 Inch FDA UDIOuter Diameter — 0.207 Inch FDA UDILength — 15.5 Centimeter FDA UDI
TightRail Mini Rotating Dilator Sheath by Spectranetics Corporation — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150360 | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K142546 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-00813132021610 | Class III | Active |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
- EUDAMED SRN
- US-MF-000020669
- FDA Applicant
- Spectranetics, Inc.
- Authorised Representative
- Spectranetics International B.V. NL-AR-000001484
Sources (3)
- EUDAMED 684eaa14-42d1-4fe8-a90d-118df4cceeab 85 fields · synced Jun 18, 2026
- FDA UDI 2863b6d1-e34f-456b-b1dd-8d7654d9fb07 36 fields · synced May 30, 2026
- FDA 510(k) K150360 1 fields · synced May 18, 2026