Atlas FDA

MEDTRONIC MODEL 5867-1A

FDA 510(k) clearance K852236 · decided 1985-07-11

Clearance details

K-number
K852236
Device name
MEDTRONIC MODEL 5867-1A
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1985-05-22
Decision date
1985-07-11
Days to decision
50 days
Clearance type
Traditional
Product code
KFJ
Device class
3
Regulation number
870.3710
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
UNIVERSAL TERMINAL CAP, 3.2MM (K913919)Telectronics Pacing Systems, Inc.1991-12-31
IMPLANT AID SPLICING CRIMP & SLEEVE (K813518)Intermedics, Inc.1982-01-12

Recalls involving this device

No recalls on record reference this clearance.

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