Atlas FDA

5F MEDTRONIC LAUNCHER GUIDE CATHETER

FDA 510(k) clearance K030779 · decided 2003-04-24

Clearance details

K-number
K030779
Device name
5F MEDTRONIC LAUNCHER GUIDE CATHETER
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2003-03-11
Decision date
2003-04-24
Days to decision
44 days
Clearance type
Special
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Danvers, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CATHETER LA5IMAA 5F 110CM Coronary Guiding catheter designed to provide a pathway through recall (Z-0930-06)Medtronic, Inc.2006-06-01
CATH.GUIDE 5F JL 4.0 110CM CATHETER LA5JL40A LA 5F 110CM JL40 Coronary Guiding catheter de recall (Z-0931-06)Medtronic, Inc.2006-06-01
CATH.GUIDE 5F JR 4.0 110CM CATHETER LA5JR40A LA 5F 110CM JR4.0 Coronary Guiding catheter d recall (Z-0932-06)Medtronic, Inc.2006-06-01
CATH GUIDE 5F SR3.0 LAUNCHER CATHETER LA5SR30 LA 5F 100CM SR30 Coronary Guiding catheter d recall (Z-0933-06)Medtronic, Inc.2006-06-01
CATH GUIDE 5F SR3.5 LAUNCHER CATHETER LA5SR35 LA 5F 100CM SR35 Coronary Guiding catheter d recall (Z-0934-06)Medtronic, Inc.2006-06-01
CATH GUIDE 5F SR4.0 LAUNCHER CATHETER LA5SR40 LA 5F 100CM SR40 Coronary Guiding catheter d recall (Z-0935-06)Medtronic, Inc.2006-06-01
CATH.GUIDE 5F SR 5.0 110CM CATHETER LA5SR50A LA 5F 110CM SR5 Coronary Guiding catheter des recall (Z-0936-06)Medtronic, Inc.2006-06-01

PMA approvals by this applicant

RecordFirmDate
Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S089)Medtronic Vascular2025-12-19
Endurant II/IIs Stent Graft System (P100021/S131)Medtronic Vascular2025-10-23
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S129)Medtronic Vascular2025-09-15
Resolute Onyx (P160043/S088)Medtronic Vascular2025-06-26
Endurant Stent Graft System (P100021/S130)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073)Medtronic Vascular2025-06-12
Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S072)Medtronic Vascular2025-05-20
Valiant Thoracic Stent Graft with the Captiva Delivery System (P100040/S069)Medtronic Vascular2025-05-08