Atlas FDA

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

FDA 510(k) clearance K232737 · decided 2023-12-08

Clearance details

K-number
K232737
Device name
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
Applicant
Bard Peripheral Vascular, Inc.
Decision
Substantially Equivalent
Date received
2023-09-07
Decision date
2023-12-08
Days to decision
92 days
Clearance type
Special
Product code
LJT
Device class
2
Regulation number
880.5965
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Tempe, AZ, 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
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
Vital-Port Vascular Access System Power Injectable Port (K150733)Cook Incorporated2015-05-21

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Fluency™ Plus Endovascular Stent Graft (P130029/S015)Bard Peripheral Vascular, Inc.2026-06-22
Venovo™ Venous Stent System (P180037/S015)Bard Peripheral Vascular, Inc.2026-06-10
LifeStent™ 5F Vascular Stent Systems (P070014/S069)Bard Peripheral Vascular, Inc.2026-06-10
Bard™ Fluency™ Plus Endovascular Stent Graft (P130029/S014)Bard Peripheral Vascular, Inc.2026-06-10
LifeStent 5F Vascular Stent System (P070014/S068)Bard Peripheral Vascular, Inc.2026-05-15
LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM (P070014/S067)Bard Peripheral Vascular, Inc.2026-03-10
LifeStent® Vascular Stent Systems (P070014/S066)Bard Peripheral Vascular, Inc.2025-12-16
LifeStream™ Balloon Expandable Vascular Covered Stent (P160024/S014)Bard Peripheral Vascular, Inc.2025-09-29