Search Results
Found 3 results
510(k) Data Aggregation
K Number
K201682Device Name
RIST Radial Access Catheter
Manufacturer
RIST Neurovascular, Inc.
Date Cleared
2020-09-28
(98 days)
Product Code
QJP, DQO
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
RIST Neurovascular, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RIST Radial Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.
Device Description
The RIST Radial Access Catheter is a flexible, single lumen catheter compatible with 0.038inch quidewires. It is designed to deliver interventional devices into the peripheral, coronary, and neuro vasculature, facilitate introduction of diagnostic agents in the neuro vasculature, and is intended to provide access to the target site via transradial access. The RIST Radial Access Catheter consists of a radiopaque catheter shaft reinforced with stainless steel and has a luer connector at its proximal end for the attachment of accessories and the infusion of fluids. The distal tip of the catheter is shaped to have a smooth, rounded tip and is offered in two different distal segment shapes, namely Simmons 2 (SIM2) and Berenstein (BER), The catheter has a nominal outer diameter of 0.070 inches and a nominal inner diameter of 0.040 inches. It is available in two working lengths: 120 cm. The RIST Radial Access Catheter is compatible with the RIST Cath Radial Access Long Sheath (K191551) and off-the-shelf accessories. The RIST Radial Access Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
Ask a Question
K Number
K200417Device Name
RIST Radial Access Catheter
Manufacturer
RIST Neurovascular, Inc.
Date Cleared
2020-05-02
(72 days)
Product Code
QJP, DOY, OJP
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
RIST Neurovascular, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RIST Radial Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Device Description
The RIST Radial Access Catheter is a flexible, single lumen catheter compatible with 0.035 inch and 0.038-inch guidewires. It is designed to deliver interventional devices into the peripheral, coronary, and neuro vasculature and is intended to provide access to the target site via transradial access. The RIST Radial Access Catheter consists of a radiopaque catheter shaft reinforced with stainless steel and has a luer connector at its proximal end for the attachment of accessories and the infusion of fluids. The distal tip of the catheter is shaped to have a smooth, rounded tip and is offered in two different distal segment shapes, namely Simmons 2 (SIM2) and Berenstein (BER). The catheter has a nominal outer diameter of 0.070 inches and a nominal inner diameter of 0.040 inches. It is available in two working lengths: 120 cm and 130 cm. The RIST Radial Access Catheter is compatible with the RIST Cath Radial Access Long Sheath (K191551) and off-theshelf accessories. The RIST Radial Access Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
Ask a Question
K Number
K191551Device Name
RIST Cath Radial Access Long Sheath
Manufacturer
RIST Neurovascular, Inc.
Date Cleared
2019-12-23
(194 days)
Product Code
DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
RIST Neurovascular, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RIST Cath Radial Access Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Device Description
The RIST Cath Radial Access Long Sheath (RIST Cath) is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft and has a radiopaque marker band on the distal end to aid in visualization. The catheter has a nominal outer diameter of 0.093 inches and a nominal inner diameter of 0.079 inches. It is available in two working lengths: 95 cm and 100 cm. The RIST Cath is intended to provide access to the target site via transradial access and once in place, provides a reinforcing conduit for other intravascular devices. The RIST Cath Radial Access Long Sheath has a PTFE-lined lumen to facilitate movement of other devices passing through its lumen. Accessories included with the device are a radial access dilator and a hemostasis valve. The RIST Cath is supplied sterile, non-pyrogenic, and intended for single use only.
Ask a Question
Page 1 of 1