Atlas FDA

MEDTRONIC #3798 ELECTRODE

FDA 510(k) clearance K812418 · decided 1981-09-16

Clearance details

K-number
K812418
Device name
MEDTRONIC #3798 ELECTRODE
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1981-08-24
Decision date
1981-09-16
Days to decision
23 days
Clearance type
Traditional
Product code
GXY
Device class
2
Regulation number
882.1320
Medical specialty
Neurology
Advisory committee
Neurology
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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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