Cardiovascular Delivery Catheter System Positioning And Stabilization Device
Cardiovascular · 21 CFR 870.3955
A cardiovascular delivery catheter system positioning and stabilization device is a platform device or a part of a platform device that aids the positioning and stabilization of delivery catheter systems during cardiovascular interventional procedures (e.g., transcatheter valvular interventions). The device only provides mechanical support and does not include any electrical or robotic components. The device may be for single use or reusable.
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
18 firms currently registered for this product code
Abbott Vascular
SANTA CLARA, CA, US
Endonest Medical Systems Llp
PALGHAR Maharashtra, IN
Edwards Lifesciences Ireland Limited
Limerick Munster, IE
Ebr Systems Inc.
Santa Clara, CA, US
Edwards Lifesciences Llc
IRVINE, CA, US
Edwards Lifesciences Ltd
Shannon Clare, IE
Abbott Vascular Netherlands
Heerlen Limburg, NL
Gcx Corporation
El Paso, TX, US
Abbott Medical
Plymouth, MN, US
Sterigenics Us Llc
Los Angeles, CA, US
Ebr Systems Inc.
Sunnyvale, CA, US
Kardium Inc.
Burnaby British Columbia, CA
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Abbott Vascular
Menlo Park, CA, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Heinrich Medizintechnik Gmbh
Stuttgart Baden-Wurttemberg, DE
Edwards Lifesciences Llc
Draper, UT, US
Abbott Medical
Saint Paul, MN, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.