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NC ROCKSTAR

Sino Medical Sciences Technology Inc. · Model NCP-3.25-15-RX · UDI-DI 06948546213239

LOX

510(k) clearances

43,618

Adverse events (585 deaths)

121

Recalls

Facilities

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).

Recalls

Date	Firm	Reason
2022-06-24	Medtronic Inc	Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29	Abbott Vascular	Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.