OPN NC PTCA Dilatation Catheter
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- OPN NC EUDAMEDFDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Device Name
- OPN NC EUDAMEDOPN NC Ø2.0x15 PTCA catheters FDA UDIOPN NC Ø4.0x20 PTCA catheters FDA UDI
- Model / Reference
- 200-015-004 EUDAMEDFDA UDI400-020-004 EUDAMEDFDA UDI
- Description
- OPN NC Ø2.0x15 PTCA catheters FDA UDIOPN NC Ø4.0x20 PTCA catheters FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640142570516 EUDAMEDFDA UDI07640142570646 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014257OPN_NCKM EUDAMED
- Direct Marketing DI
- 07640142570646 EUDAMED07640142570516 EUDAMED
- 510(k) Number
- FDA Product Code
- LOX FDA 510(k)FDA UDI
- EMDN Code
- C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED
- GMDN Term
- Coronary angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.5100 FDA 510(k)
- Regulation Number
- 870.5100 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
The OPN NC PTCA Dilatation Catheter is a Transluminal Coronary Angioplasty Catheter, designed for percutaneous dilation of coronary arteries. It employs a balloon mechanism to mechanically widen narrowed or obstructed coronary vessels, restoring blood flow to myocardial tissue. This device is classified under Class II medical devices and is intended for use in interventional cardiology procedures.
The catheter is supplied as a single-use, sterile device and is intended for use in controlled clinical settings such as catheterization laboratories. It is compatible with standard coronary angiography systems and is available in various sizes as specified in the regulatory filings. Authorized under FDA 510K and MDR, it adheres to strict manufacturing and quality control standards to ensure safety and efficacy in coronary revascularization procedures.
Frequently asked questions
What clinical setting is the OPN NC PTCA Dilatation Catheter designed for use in?
The OPN NC PTCA Dilatation Catheter is designed exclusively for use in controlled clinical settings such as catheterization laboratories. This is because it is a single-use, sterile device intended for percutaneous dilation of coronary arteries during interventional cardiology procedures, where precise control and sterile conditions are critical.
Are there multiple sizes available for the OPN NC PTCA Dilatation Catheter, and how would I determine which one to use?
Yes, the OPN NC PTCA Dilatation Catheter is available in various sizes, as indicated in the regulatory filings. The specific size selection should be based on the anatomical requirements of the patient’s coronary arteries, ensuring compatibility with the narrowed or obstructed vessel to be treated. Consulting the manufacturer’s guidelines or a product datasheet will help match the correct size to the clinical scenario.
How is the OPN NC PTCA Dilatation Catheter supplied, and what are the implications for its use?
The OPN NC PTCA Dilatation Catheter is supplied as a single-use, sterile device. This means each catheter is intended for one procedure only and must remain unopened until use. The sterile packaging ensures safety and efficacy, reducing the risk of infection, and aligns with best practices for interventional cardiology procedures where sterility is paramount.
What regulatory pathways has the OPN NC PTCA Dilatation Catheter followed, and what does this mean for its use?
The OPN NC PTCA Dilatation Catheter has undergone regulatory review through the FDA 510(k) pathway and the EU Medical Device Regulation (MDR). The FDA 510(k) clearance and MDR authorization indicate that the device has met stringent safety and performance standards required for Class II medical devices in the respective regions. This ensures compliance with regulatory requirements for use in percutaneous coronary interventions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212393 | Class II | Active |
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Manufacturer
- Manufacturer
- SIS Medical AG
Sources (5)
- FDA 510(k) K212393 24 fields · synced Sep 18, 2026
- FDA UDI efa47ec2-b366-46e9-8ad9-3c6671978fb2 35 fields · synced May 30, 2026
- FDA UDI 555045b5-2521-4416-9aa5-95d51f18fe51 35 fields · synced May 30, 2026
- EUDAMED 386dd2f3-b14b-4ac4-ba68-3ae761473968 61 fields · synced Jul 18, 2026
- EUDAMED e2d87c23-9526-40c9-a5f7-25dd52e9a399 61 fields · synced Jul 28, 2026