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Visions PV .014P RX Digital IVUS Catheter
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref 014R510(k) K253399
Identity
- Trade Name
- Visions PV .014P RX Digital IVUS Catheter EUDAMEDFDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, single-use FDA UDI
- Device Name
- Visions PV EUDAMED
- Model / Reference
- 014R EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 014R FDA UDI
- Primary DI / UDI-DI
- 00845225002848 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845225002848 EUDAMED
- 510(k) Number
- K152829 FDA UDI
- FDA Product Code
- OBJ FDA UDIITX 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 UDI892.1570 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 — 150 Centimeter FDA UDI
Visions PV .014P RX Digital IVUS Catheter by Philips Image Guided Therapy Corporation — Class III — FDA_510K, MDD, MDR — listed in EUDAMED, FDA GUDID, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253399 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-00845225002848 | Class III | Active |
| EUDAMED | European Union | CE/MDR | B-00845225002848 | Class III | Active |
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Manufacturer
- Manufacturer
- Volcano Corporation
- EUDAMED SRN
- US-MF-000020094
- FDA Applicant
- Volcano Corporation (Dba Philips Image Guided Therapy Device
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (3)
- EUDAMED d2e94df6-83e8-4d58-8baf-6c82624ec254 85 fields · synced Jun 18, 2026
- FDA UDI 28d7f397-a80d-4787-b53b-ce1000df99ac 37 fields · synced May 29, 2026
- FDA 510(k) K253399 1 fields · synced May 18, 2026