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SC HONKYTONK

Sino Medical Sciences Technology Inc. · Model SCB-3.00-30-RX · UDI-DI 06948546214366

LOX
1
510(k) clearances
43,618
Adverse events (585 deaths)
121
Recalls
77
Facilities

Description

The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Recalls

DateFirmReason
2022-06-24Medtronic IncLuer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29Abbott VascularCoronary 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.