Identity
- Trade Name
- NC ROCKSTAR FDA UDI
- Generic Name
- Coronary angioplasty balloon catheter, basic FDA UDI
- Device Name
- The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting). FDA UDI
- Model / Reference
- NCP-2.50-15-RX FDA UDI
- Description
- The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06948546213116 FDA UDI
- 510(k) Number
- K222538 FDA UDI
- FDA Product Code
- LOX FDA UDI
- GMDN Term
- Coronary angioplasty balloon catheter, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coronary angioplasty balloon catheter, basic
Nc Rockstar by Sino Medical Sciences Technology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K222538 also covers:
- NC ROCKSTAR — Sino Medical Sciences Technology Inc.
- NC ROCKSTAR — Sino Medical Sciences Technology Inc.
- NC ROCKSTAR — Sino Medical Sciences Technology Inc.
- NC ROCKSTAR — Sino Medical Sciences Technology Inc.
- NC ROCKSTAR — Sino Medical Sciences Technology Inc.
- NC ROCKSTAR — Sino Medical Sciences Technology Inc.
- NC ROCKSTAR — Sino Medical Sciences Technology Inc.
- NC ROCKSTAR — Sino Medical Sciences Technology Inc.
- NC ROCKSTAR — Sino Medical Sciences Technology Inc.
- NC ROCKSTAR — Sino Medical Sciences Technology Inc.
- NC ROCKSTAR — Sino Medical Sciences Technology Inc.
- NC ROCKSTAR — Sino Medical Sciences Technology Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sino Medical Sciences Technology Inc.
Sources (1)
- FDA UDI 5f3b2081-61d6-4a25-932c-71fc36d7b2ab 35 fields · synced Jun 1, 2026