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Visions PV .018 Digital IVUS Catheter
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 86700
Identity
- Trade Name
- Visions PV .018 Digital IVUS Catheter EUDAMEDFDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, single-use FDA UDI
- Device Name
- Visions PV EUDAMED
- Model / Reference
- 86700 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 86700 FDA UDI
- Primary DI / UDI-DI
- 00184360000037 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00184360000037 EUDAMED
- 510(k) Number
- K150442 FDA UDI
- FDA Product Code
- OBJ FDA UDI
- EMDN Code
- C0104020102 INTRAVASCULAR ULTRASOUND CATHETERS EUDAMED
- GMDN Term
- Intravascular ultrasound imaging catheter, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Market of Registration
- Belgium 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
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
Dimensions & Sizes
- Size
- Length — 135 Centimeter FDA UDI
Visions PV .018 Digital IVUS Catheter by Volcano Corporation — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K150442 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00184360000037 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Volcano Corporation
- EUDAMED SRN
- US-MF-000020094
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (3)
- EUDAMED 4501cdfc-bcc7-49b2-87bd-35de1904a58a 61 fields · synced Jul 13, 2026
- FDA UDI dec1411b-97b1-46d7-94a5-0a4916809300 37 fields · synced May 29, 2026
- FDA 510(k) K150442 1 fields · synced May 18, 2026