Atlas FDA

Z3 GUIDE CATHETER

FDA 510(k) clearance K021256 · decided 2002-05-17

Clearance details

K-number
K021256
Device name
Z3 GUIDE CATHETER
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2002-04-19
Decision date
2002-05-17
Days to decision
28 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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CPS Locator 3D Plus Delivery Catheter (K261766)CenterPoint Systems, LLC2026-07-29
SSPC NXT Delivery Catheter (K262240)CenterPoint Systems, LLC2026-07-29
Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter (K261825)Abbott2026-07-02
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Perfect-O Ostial Positioning Catheter (K260289)Balosmark, Inc.2026-06-05
Amplatzer TorqVue Delivery System (K260993)Abbott2026-04-24
Teleport Glide Microcatheter (K253361)OrbusNeich Medical (Shenzhen) Co., Ltd.2026-04-10
Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (K260499)ABBOTT MEDICAL2026-03-13
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409)Medtronic, Inc.2025-12-19
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Telescope Guide Extension Catheter (K252390)Medtronic, Ireland2025-10-29
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Recalls involving this device

RecordFirmDate
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K recall (Z-0205-2015)Medtronic Vascular2014-11-13
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # recall (Z-1564-2013)Medtronic Inc. Cardiac Rhythm Disease Management2013-06-21
CATH. GUIDE 6F 3DRC LAUNCHER CATHETER LA63DRC LA 6F 100CM 3DRC Coronary Guiding catheter d recall (Z-0937-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F 3DRC W/SH LAUNC CATHETER LA63DRCSH LA 6F 100CM 3DRC Coronary Guiding cathet recall (Z-0938-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F AL 1.0 110CM LA CATHETER LA6AL10A LA 6F 110CM AL10 Coronary Guiding cathete recall (Z-0939-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F AL 2.0 110CM LA CATHETER LA6AL20A LA 6F 110CM AL20 Coronary Guiding cathete recall (Z-0940-06)Medtronic, Inc.2006-06-01
CATH GUIDE 6F LAUNCHER AL 3.0 CATHETER LA6AL30A LA 6F 110CM AL30 Coronary Guiding catheter recall (Z-0941-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F EBU3.5 110CM LA CATHETER LA6EBU35A LA 6F 110CM EB35 Coronary Guiding cathet recall (Z-0942-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F EBU4.0 110CM LA CATHETER LA6EBU40A LA 6F 110CM EB40 Coronary Guiding cathet recall (Z-0943-06)Medtronic, Inc.2006-06-01
CATH GUIDE 6F LAUNCHER EBU 4.5 CATHETER LA6EBU45A LA 6F 110CM EB45 Coronary Guiding cathet recall (Z-0944-06)Medtronic, Inc.2006-06-01
CATHETER LA6HSIA 6F 110CM HSI Coronary Guiding catheter designed to provide a pathway thro recall (Z-0945-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F JL3.5 110CM LAU CATHETER LA6JL35A LA 6F 110CM JL35 Coronary Guiding cathete recall (Z-0946-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F JL4.0 5 PACK LA Coronary Guiding catheter designed to provide a pathway thr recall (Z-0947-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F JL4.0 110CM LAU CATHETER LA6JL40A LA 6F 110CM JL40 Coronary Guiding cathete recall (Z-0948-06)Medtronic, Inc.2006-06-01
CATH.GUIDE 6F JL 4.0 SH 110CM CATHETER LA6JL40SHA LA 6F 110CM JL40 Coronary Guiding cathet recall (Z-0949-06)Medtronic, Inc.2006-06-01
CATHETER LA6JL45A 6F 110CM JL4 CATHETER LA6JL45A 6F 110CM JL45 Coronary Guiding catheter d recall (Z-0950-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F JL5.0 110CM LAU CATHETER LA6JL50A LA 6F 110CM JL50 Coronary Guiding cathete recall (Z-0951-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F JR4.0 110CM LAU CATHETER LA6JR40A LA 6F 110CM JR40 Coronary Guiding cathete recall (Z-0952-06)Medtronic, Inc.2006-06-01
CATH.GUIDE 6F JR 4.0 SH 110CM CATHETER LA6JR40SHA LA 6F 110CM JR40 Coronary Guiding cathet recall (Z-0953-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F JR5.0 110CM LAU CATHETER LA6JR50A LA 6F 110CM JR50 Coronary Guiding cathete recall (Z-0954-06)Medtronic, Inc.2006-06-01
CATHETER LA6MB1A LA 6F 110CM M Coronary Guiding catheter designed to provide a pathway thr recall (Z-0955-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F SR3.0 LAUNCHER CATHETER LA6SR30 LA 6F 100CM SR30 Coronary Guiding catheter recall (Z-0956-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F SR3.0 W/SH LAUN CATHETER LA6SR30SH LA 6F 100CM SR30 Coronary Guiding cathet recall (Z-0957-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F SR3.5 LAUNCHER CATHETER LA6SR35 LA 6F 100CM SR35 Coronary Guiding catheter recall (Z-0958-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F SR3.5 W/SH LAUN CATHETER LA6SR35SH LA 6F 100CM SR35 Coronary Guiding cathet recall (Z-0959-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F SR4.0 LAUNCHER CATHETER LA6SR40 LA 6F 100CM SR40 Coronary Guiding catheter recall (Z-0960-06)Medtronic, Inc.2006-06-01
CATHETER LA6SR40A 6F 110CM SR4 CATHETER LA6SR40A 6F 110CM SR40 Coronary Guiding catheter d recall (Z-0961-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F SR4.0 W/SH LAUN CATHETER LA6SR40SH LA 6F 100CM SR40 Coronary Guiding cathet recall (Z-0962-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F SR4.5 LAUNCHER CATHETER LA6SR45 LA 6F 100CM SR45 Coronary Guiding catheter recall (Z-0963-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F SR4.5 W/SH LAUN CATHETER LA6SR45SH LA 6F 100CM SR45 Coronary Guiding cathet recall (Z-0964-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F SR5.0 LAUNCHER CATHETER LA6SR50 LA 6F 100CM SR50 Coronary Guiding catheter recall (Z-0965-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F SR5.0 W/SH LAUN CATHETER LA6SR50SH LA 6F 100CM SR50 Coronary Guiding cathet recall (Z-0966-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F SR6.0 LAUNCHER CATHETER LA6SR60 LA 6F 100CM SR60 Coronary Guiding catheter recall (Z-0967-06)Medtronic, Inc.2006-06-01
CATH. GUIDE 6F SR6.0 W/SH LAUN Coronary Guiding catheter designed to provide a pathway thr recall (Z-0968-06)Medtronic, Inc.2006-06-01
CATHETER SA63DRC SA 6F 100CM 3 CATHETER SA63DRC SA 6F 100CM 3DRC Coronary Guiding catheter recall (Z-0996-06)Medtronic, Inc.2006-06-01
CATHETER SA63DRCSH Coronary Guiding catheter designed to provide a pathway through which t recall (Z-0997-06)Medtronic, Inc.2006-06-01
CATHETER SA6SR35 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway throu recall (Z-0998-06)Medtronic, Inc.2006-06-01
CATHETER SA6SR40 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway throu recall (Z-0999-06)Medtronic, Inc.2006-06-01
CATHETER SA6SR50 SA 6F 100CM Coronary Guiding catheter designed to provide a pathway throu recall (Z-1000-06)Medtronic, Inc.2006-06-01
CATHETER SB63DRC SB 6F 100CM 3 CATHETER SB63DRC SB 6F 100CM 3DRC Coronary Guiding catheter recall (Z-1001-06)Medtronic, Inc.2006-06-01
CATHETER SB63DRCSH SB 6F 100CM Coronary Guiding catheter designed to provide a pathway thr recall (Z-1002-06)Medtronic, Inc.2006-06-01
CATHETER SB6SR30 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway thr recall (Z-1003-06)Medtronic, Inc.2006-06-01
CATHETER SB6SR35 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway thr recall (Z-1004-06)Medtronic, Inc.2006-06-01
CATHETER SB6SR35SH SB 6F 100CM Coronary Guiding catheter designed to provide a pathway thr recall (Z-1005-06)Medtronic, Inc.2006-06-01
CATHETER SB6SR40 SB 6F 100CM S CATHETER SB6SR40 SB 6F 100CM SR40 Coronary Guiding catheter recall (Z-1006-06)Medtronic, Inc.2006-06-01
CATHETER SB6SR40SH SB 6F 100CM Coronary Guiding catheter designed to provide a pathway thr recall (Z-1007-06)Medtronic, Inc.2006-06-01
CATHETER SB6SR50 SB 6F 100CM S Coronary Guiding catheter designed to provide a pathway thr recall (Z-1008-06)Medtronic, Inc.2006-06-01
CATH, GUIDE 6F JR4.0 SH 110CM Coronary Guiding catheter designed to provide a pathway thro recall (Z-1019-06)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