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SoloPath® Re-Collapsible Access System INSTRUCTIONS …
- https://www.terumo-europe.com/Relevant%20Product%20Info/solopath-re-collapsible-multi-lingual-ifu.pdf
- The SoloPath® with its integral balloon Expander is advanced as a single unit, under fluoroscopic control, over the 0.038” (0.97mm) guidewire until its distal radiopaque sheath marker is positioned at the desired location within the vasculature. Caution: The …
Onset Medical Receives CE Mark Clearance to Market …
- https://www.biospace.com/article/releases/onset-medical-receives-ce-mark-clearance-to-market-solopath-tm-percutaneous-transseptal-access-catheter-/
- SoloPath utilizes Onset’s patented Controlled Deployment Technology (“CDT”), to allow percutaneous access to the chambers of the left heart and …
Use of the Solopath™ Re-collapsible Balloon Access …
- https://www.radcliffecardiology.com/articles/use-solopathtm-re-collapsible-balloon-access-system-troublesome-femoral-access-porticotm
- Solopath is a trademark of Onset Medical Corporation. Terumo may distribute. Prostar is a trademark of Abbott Vascular. References Ducrocq G, Francis F, Serfaty JM, et al., Vascular complications of transfemoral …
FDA Clears Onset Medical SoloPath Endovascular Access Catheter
- https://www.nsmedicaldevices.com/news/fda_clears_onset_medical_solopath_endovascular_access_catheter_100811/
- Onset Medical has received FDA 510(k) marketing clearance for new access applications of the SoloPath TransFemoral Endovascular Access Catheter. With the FDA …
Onset Medical's SoloPath Endovascular Access Catheter …
- https://www.nsmedicaldevices.com/news/onset_medicals_solopath_endovascular_access_catheter_receives_european_ce_mark_p_090729/
- The SoloPath catheter uses Onset’s Controlled Deployment Technology (“CDT”) in a different approach to procedures that require minimally invasive access to …
510(k) Premarket Notification
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?start_search=1&productcode=DYB&applicant=ONSET%20MEDICAL%20CORPORATION
- solopath re-collapsible access system: ONSET MEDICAL CORPORATION K121404: 05/03/2013 the solopath balloon expandable transfemoral introducer: ONSET …
SoloPathO Re-Collapsib le Access System MAY 03 …
- https://www.accessdata.fda.gov/cdrh_docs/pdf12/K121404.pdf
- Onset Medical Corporation's SoloPath® Re-Collapsible Access System is a sterile, single use device. Itconsists of a flexible, reinforced polymer sheath with an external collapsible …
MAUDE Adverse Event Report: ONSET MEDICAL …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2794073
- The solopath sheath was partially collapsed 21cm along the length of the original fold lines. The avulsed artery was removed from the solopath sheath, measured and …
MAUDE Adverse Event Report: ONSET MEDICAL …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2782984
- F/u injection of contrast reveals smooth edges of sheath and gore 28. 5mm endurant main body inserted thru solopath sheath after lubrication with propofol to ease insertion. Graft …
MAUDE Adverse Event Report: ONSET MEDICAL …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4392115
- Follow up communication with the user facility confirmed the following: solopath recollapsible 1925 was used in a subclavian cut down access; sheath inserted and …
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