Identity
- Trade Name
- RapidCross™ EUDAMEDFDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, basic FDA UDI
- Device Name
- Rapidcross PTA Catheter EUDAMEDPTA A14BX020060170 RAPIDCROSS V05 FDA UDI
- Model / Reference
- A14BX020060170 EUDAMEDFDA UDI
- Description
- PTA A14BX020060170 RAPIDCROSS V05 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000756444 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763000B00006898N EUDAMED
- 510(k) Number
- K130911 FDA UDI
- FDA Product Code
- LIT FDA UDI
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
- GMDN Term
- Peripheral angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Balloon Length — 60.0 Millimeter FDA UDICatheter Working Length — 170.0 Centimeter FDA UDIBalloon Diameter — 2.0 Millimeter FDA UDI
Category: Peripheral angioplasty balloon catheter, basic
RapidCross™ by Medtronic, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
- Advocate™ — Merit Medical Systems, Inc. · Class II
- Senri — KANEKA Corporation · Class IIa
- Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
- ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
- RapidCross — Covidien LP · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0763000B00006898N | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
- EUDAMED SRN
- US-MF-000019977
- Authorised Representative
- Medtronic B.V. NL-AR-000006050
Sources (2)
- EUDAMED 2227423d-790d-4a5d-b341-4046ada651e9 61 fields · synced Sep 17, 2026
- FDA UDI 6098cdfd-3843-47cd-8fa1-bcd99eefea8d 37 fields · synced May 29, 2026