FDA.reportPublic FDA data

NC ROCKSTAR

Primary DI
06948546213192
Brand
NC ROCKSTAR
Company
Sino Medical Sciences Technology Inc.
Model
NCP-3.00-15-RX
Device 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).
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222538000NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation CatheterSino Medical Sciences Technology, Inc.2022-12-21LOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948546213192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948546213192069485462131926948546213192

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, basicA flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry, dark place.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528191055
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06948546214045SC HONKYTONKSCB-1.50-09-RX2023-08-04
06948546214052SC HONKYTONKSCB-1.50-15-RX2023-08-04
06948546214069SC HONKYTONKSCB-1.50-20-RX2023-08-04
06948546214076SC HONKYTONKSCB-2.00-09-RX2023-08-04
06948546214083SC HONKYTONKSCB-2.00-15-RX2023-08-04
06948546214090SC HONKYTONKSCB-2.00-20-RX2023-08-04
06948546214106SC HONKYTONKSCB-2.00-25-RX2023-08-04
06948546214113SC HONKYTONKSCB-2.25-09-RX2023-08-04
06948546214120SC HONKYTONKSCB-2.25-15-RX2023-08-04
06948546214137SC HONKYTONKSCB-2.25-20-RX2023-08-04
06948546214144SC HONKYTONKSCB-2.25-25-RX2023-08-04
06948546214151SC HONKYTONKSCB-2.25-30-RX2023-08-04
06948546214168SC HONKYTONKSCB-2.25-35-RX2023-08-04
06948546214175SC HONKYTONKSCB-2.50-09-RX2023-08-04
06948546214182SC HONKYTONKSCB-2.50-12-RX2023-08-04
06948546214199SC HONKYTONKSCB-2.50-15-RX2023-08-04
06948546214205SC HONKYTONKSCB-2.50-20-RX2023-08-04
06948546214212SC HONKYTONKSCB-2.50-25-RX2023-08-04
06948546214229SC HONKYTONKSCB-2.50-30-RX2023-08-04
06948546214236SC HONKYTONKSCB-2.50-35-RX2023-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810219610071FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
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00810219610095FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610101FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
00810219610118FLASH Flex Aorto-Ostial Angioplasty SystemVerge Medical, Inc.LOX2026-05-22
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06971591769123Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769130Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
06971591769147Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOX2026-04-19
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