← Back to catalogue
Visions PV .035 Digital IVUS Catheter
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref 88901
Identity
- Trade Name
- Visions PV .035 Digital IVUS Catheter EUDAMEDFDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, single-use FDA UDI
- Device Name
- Visions PV EUDAMED
- Model / Reference
- 88901 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 88901 FDA UDI
- Primary DI / UDI-DI
- 00845225002329 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845225002329 EUDAMED
- 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 III 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
- Outer Diameter — .055 Inch FDA UDILength — 90 Centimeter FDA UDI
Visions PV .035 Digital IVUS Catheter by Volcano 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 | K121273 | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K153094 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-00845225002329 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Volcano Corporation
- EUDAMED SRN
- US-MF-000020094
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (3)
- EUDAMED 9a41042d-73aa-4f3f-a731-b591a5f77964 61 fields · synced Aug 5, 2026
- FDA UDI 7c929e52-5b80-496b-90a5-fad593339dd8 36 fields · synced May 27, 2026
- FDA 510(k) K121273 1 fields · synced May 18, 2026