Atlas FDA

5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER

FDA 510(k) clearance K132673 · decided 2013-10-22

Clearance details

K-number
K132673
Device name
5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2013-08-27
Decision date
2013-10-22
Days to decision
56 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
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use recall (Z-2562-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDND1 55CM .070", REF SA6RDND1K. for cardiovascular recall (Z-2563-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, 3DRC 100CM .070", REF SA63DRC. for cardiovascular u recall (Z-2564-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular recall (Z-2565-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 90CM.070", REF SA6AL10D. for cardiovascular u recall (Z-2566-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL3.0 110CM.070", REF SA6AL30A. for cardiovascular recall (Z-2567-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL.75 110CM.070", REF SA6AL75A. for cardiovascular recall (Z-2568-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. for cardiovascular u recall (Z-2569-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. for cardiovascul recall (Z-2570-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for cardiovascular recall (Z-2571-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. for cardiovasc recall (Z-2572-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5, 100CM.070", REF SA6CHAMP05. for cardiovas recall (Z-2573-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP0.5 SH, 100CM.070", REF SA6CHAMP05SH. for card recall (Z-2574-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, CHAMP2.0, 55CM.070", REF SA6CHAMP20K. for cardiovas recall (Z-2575-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 110CM.070", REF SA6EBU35A. for cardiovascul recall (Z-2576-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 90CM.070", REF SA6EBU35D. for cardiovascula recall (Z-2577-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU4.0, 110CM.070", REF SA6EBU40A. for cardiovascul recall (Z-2578-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0, 100CM.070", REF SA6FL40. for cardiovascular recall (Z-2579-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, FL4.0 SH, 100CM, 070", REF SA6FL40SH. for cardiovas recall (Z-2580-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI, 100CM, 070", REF SA6HSI. for cardiovascular us recall (Z-2581-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI SH, 100CM, 070", REF SA6HSISH . for cardiovascu recall (Z-2582-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 100CM, 070", REF SA6IMA. for cardiovascular us recall (Z-2583-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 90CM, 070", REF SA6IMAD . for cardiovascular u recall (Z-2584-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 100CM, 070", REF SA6IMASH. for cardiovascul recall (Z-2585-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 60CM, 070", REF SA6IMASHJ. for cardiovascul recall (Z-2586-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JCR4.0, 100CM, 070", REF SA6JCR40. for cardiovascul recall (Z-2587-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL3.5, 110CM, 070", REF SA6JL35A. for cardiovascula recall (Z-2588-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 110CM, 070", REF SA6JL40A. for cardiovascula recall (Z-2589-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL4.0, 90CM, 070", REF SA6JL40D. for cardiovascular recall (Z-2590-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JL5.0, 110CM, 070", REF SA6JL50A. for cardiovascula recall (Z-2591-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 110CM, 070", REF SA6JR40A. for cardiovascula recall (Z-2592-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 90CM, 070", REF SA6JR40D. for cardiovascular recall (Z-2593-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 55CM, 070", REF SA6JR40K. for cardiovascular recall (Z-2594-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, LCB SH, 90CM, 070", REF SA6LCBSHD. for cardiovascul recall (Z-2595-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, MB1, 90CM, 070", REF SA6MB1D. for cardiovascular us recall (Z-2596-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, MP1, 55CM, 070", REF SA6MP1K. for cardiovascular us recall (Z-2597-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, MPH, 55CM, 070", REF SA6MPHK. for cardiovascular us recall (Z-2598-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for cardiovascular recall (Z-2599-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO SH, 100CM, 070", REF SA6NOTOSH. for cardiovasc recall (Z-2600-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, PK1, 47CM, 070", REF SA6PK1W. for cardiovascular us recall (Z-2601-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5, 100CM, 070", REF SA6RBU35. for cardiovascul recall (Z-2602-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5 SH, 100CM, 070", REF SA6RBU35SH. for cardiov recall (Z-2603-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB, 90CM, 070", REF SA6RCBD. for cardiovascular us recall (Z-2604-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. for cardiovascul recall (Z-2605-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, RDC, 55CM, 070", REF SA6RDCK. for cardiovascular us recall (Z-2606-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR3.0, 100CM, 070", REF SA6SR30. for cardiovascular recall (Z-2607-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0, 100CM, 070", REF SA6SR40. for cardiovascular recall (Z-2608-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0 SH, 100CM, 070", REF SA6SR40SH. for cardiovas recall (Z-2609-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F 100CM 3DRC, REF SA63DRCSH. for cardiovascular use recall (Z-2610-2019)Medtronic Vascular2019-10-01
SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20, REF SA6AL20A. for cardiovascular use recall (Z-2611-2019)Medtronic Vascular2019-10-01

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