Search Results
Found 2 results
510(k) Data Aggregation
K Number
K153682Device Name
Chocolate XD PTCA Balloon Catheter
Manufacturer
TriReme Medical, LLC
Date Cleared
2016-06-23
(184 days)
Product Code
LOX
Regulation Number
870.5100Why did this record match?
Applicant Name (Manufacturer) :
TriReme Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chocolate™ XD PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion including in-stent restenosis.
Device Description
The Chocolate XD PTCA Balloon Catheter is a Rapid Exchange (RX) angioplasty balloon catheter. It consists of a stainless steel hypotube and a nylon shaft, a semi compliant balloon at the distal end of the catheter with a metal constraining structure (CS) and an atraumatic distal tip. Upon inflation, the CS expands with the balloon to a certain diameter; the balloon continues the expansion beyond the CS. Upon deflation, the CS returns to its original shape, and is removed from the vessel along with the balloon catheter. Two Radiopaque markers define the working length of the Chocolate Balloon. The proximal end of the catheter is comprised of a hub used to inflate the balloon that can be connected to a standard inflation device. The catheter will be 140 ±5cm in length, compatible with 0.014" guidewire.
Ask a Question
K Number
K150292Device Name
Chocolate PTCA Balloon Catheter
Manufacturer
TRIREME MEDICAL, LLC
Date Cleared
2015-04-09
(62 days)
Product Code
LOX
Regulation Number
870.5100Why did this record match?
Applicant Name (Manufacturer) :
TRIREME MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chocolate™ PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
Device Description
The hydrophilic coated Chocolate PTCA Balloon Catheter is a Rapid Exchange (RX) angioplasty balloon catheter. It consists of a stainless steel hypotube and a nylon shaft, a semi compliant balloon at the distal end of the catheter with a metal constraining structure (CS) and an atraumatic distal tip. Upon inflation, the CS expands with the balloon to a certain diameter; the balloon continues the expansion beyond the CS. Upon deflation, the CS returns to its original shape, and is removed from the vessel along with the balloon catheter. Two Radiopaque markers are added to define the working length of the Chocolate Balloon. The proximal end of the catheter is comprised of a hub used to inflate the balloon that can be connected to a standard inflation device. The catheter will be 140 ±5cm in length, compatible with 0.014" guidewire. The catheter shaft is hydrophilic coated.
Ask a Question
Page 1 of 1