510(k) K101497 · DYB Introducer, Catheter

DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY

Applicant	Oscor, Inc., Palm Harbor FL, US
Decision	Substantially Equivalent, Oct 20, 2010
Received	Jun 1, 2010
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K101497

Date	Firm and product	Code	Linked 510(k)
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C55 S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C70 S61CM D66CM Catalog # AB081041 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C90 S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C120 S61CM D66CM Catalog # AB081043 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C55 S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C70 S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C90 S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctur Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C120 S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal pu Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C55 S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C70 S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C120 S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punc Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C55 S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C70 S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C90 S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C120 S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punc Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the lef Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70 S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the l Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90 S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the lef Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120 S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the le Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the lef Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70 S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the lef Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90 S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the lef Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90 S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left Terminated	DYB	None listed
Oct 5, 2016	Oscor, Inc. MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left Terminated	DYB	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.