Atlas FDA

MEDTRONIC MODEL 8501 ACCESS PORT

FDA 510(k) clearance K861498 · decided 1986-06-12

Clearance details

K-number
K861498
Device name
MEDTRONIC MODEL 8501 ACCESS PORT
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1986-04-23
Decision date
1986-06-12
Days to decision
50 days
Clearance type
Traditional
Product code
LJT
Device class
2
Regulation number
880.5965
Medical specialty
General Hospital
Advisory committee
General Hospital
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
FLEXI-PORT™ Power Injectable Implantable Port (K260916)Portal Access, Inc.2026-06-17
Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable Port (K252478)Bard Access Systems, Inc.2025-09-05
PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port (K251253)Bard Access Systems, Inc.2025-06-18
PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports (K242328)Bard Access Systems, Inc.2024-10-31
PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port (K232737)Bard Peripheral Vascular, Inc.2023-12-08
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports (K190559)AngioDynamics, Inc.2020-05-22
Bard Power-Injectable Implantable Ports (PowerPorts®) (K181446)C.R. Bard, Inc.2019-07-08
NMI DUAL PORT II (K151239)Navilyst Medical, Inc.2016-06-06
BardPort®, SlimPort®, and X-Port® Implanted Ports (K153359)C.R. Bard, Inc.2016-05-20
Dignity Dual Port (K153238)Medcomp ( Medical Components)2016-03-15
NMI Port, NMI Port II (K153228)Navilyst Medical, Inc.2015-12-04
Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters (K150514)C.R. Bard, Inc.2015-11-20

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