Atlas FDA

7F LAUNCHER GUIDE CATHETER

FDA 510(k) clearance K022764 · decided 2002-08-28

Clearance details

K-number
K022764
Device name
7F LAUNCHER GUIDE CATHETER
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2002-08-21
Decision date
2002-08-28
Days to decision
7 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
CATH. GUIDE 7F 3DRCC LAUNCHER CATHETER LA73DRC LA 7F 100CM 3DRC Coronary Guiding catheter recall (Z-0969-06)Medtronic, Inc.2006-06-01
CATHETER LA7IMAA LA 7F 110CM I CATHETER LA7IMAA LA 7F 110CM IMA Coronary Guiding catheter recall (Z-0970-06)Medtronic, Inc.2006-06-01
CATHETER LA7MB1A LA 7F 110CM M CATHETER LA7MB1A LA 7F 110CM MB Coronary Guiding catheter d recall (Z-0971-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 7F SR3.0 LAUNCHER CATHETER LA7SR30 LA 7F 100CM SR30 Coronary Guiding catheter recall (Z-0972-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 7F SR3.0 W/SH LAUN CATHETER LA7SR30SH LA 7F 100CM SR30 Coronary Guiding cathet recall (Z-0973-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 7F SR3.5 LAUNCHER CATHETER LA7SR35 LA 7F 100CM SR35 Coronary Guiding catheter recall (Z-0974-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 7F SR3.5 W/SH LAUN CATHETER LA7SR35SH LA 7F 100CM SR35 Coronary Guiding cathet recall (Z-0975-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 7F SR4.0 LAUNCHER CATHETER LA7SR40 LA 7F 100CM SR40 Coronary Guiding catheter recall (Z-0976-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 7F SR4.0 W/SH LAUN CATHETER LA7SR40SH LA 7F 100CM SR40 Coronary Guiding cathet recall (Z-0977-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 7F SR4.0 LAUNCHER CATHETER LA7SR40 LA 7F 100CM SR40 Coronary Guiding catheter recall (Z-0978-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 7F SR4.0 W/SH LAUN CATHETER LA7SR40SH LA 7F 100CM SR40 Coronary Guiding cathet recall (Z-0979-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 7F SR5.0 LAUNCHER CATHETER LA7SR50 LA 7F 100CM SR50 Coronary Guiding catheter recall (Z-0980-06)Medtronic, Inc.2006-06-01
CATHETER SB73DRCSH SB 7F 100CM Coronary Guiding catheter designed to provide a pathway thr recall (Z-1009-06)Medtronic, Inc.2006-06-01

PMA approvals by this applicant

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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