510(k) K232737
- Device
- 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.
- 510(k) number
- K232737
- Product code
- LJT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-08
- Date received
- 2023-09-07
- Regulation
- 880.5965
- Classification name
- Port & Catheter, Implanted, Subcutaneous, Intravascular
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Kristen Ortiz
- Address
- 1625 W. 3rd St. Tempe AZ US 85281 85281
FDA Registration Numbers
- 1048735
- 9611665
- 3008537309
- 1018233
- 3003700453
- 3026560514
- 2518902
- 3015531529
- 1061124
- 3013666218
- 9617592
- 3011088743
- 1450392
- 2030624
- 3006942524
- 3010041511
- 3012494290
- 1319211
- 1222928
- 3007156625
- 3006260740
- 9680794
- 3005232773
- 3010149039
- 2032112
- 1223004
- 1000523114
- 3009888344
- 3009746061
- 3042205359
- 3006082230
- 3004407880
- 1220905
- 3013557562
- 3015537049
- 2246552
- 3011237770
- 2011171
- 3011534620
- 1000393132
- 1219930
- 1820334
- 9617604
- 3018094310
- 3015859709
- 3013750125
- 3012307300
- 1319639
- 3006425876
- 3003678543
- 9681202
- 3007939342
- 8020785
- 9612452
- 2245270
- 3003915875
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code LJT
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port | Bard Access Systems, Inc. | 2025-09-05 |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port | Bard Access Systems, Inc. | 2025-06-18 |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports | Bard Access Systems, Inc. | 2024-10-31 |
| K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | AngioDynamics, Inc. | 2020-05-22 |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | C.R. Bard, Inc. | 2019-07-08 |
| K151239 | NMI DUAL PORT II | Navilyst Medical, Inc. | 2016-06-06 |
| K153359 | BardPort®, SlimPort®, and X-Port® Implanted Ports | C.R. Bard, Inc. | 2016-05-20 |
| K153238 | Dignity Dual Port | Medcomp ( Medical Components) | 2016-03-15 |
| K153228 | NMI Port, NMI Port II | Navilyst Medical, Inc. | 2015-12-04 |
| K150514 | Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters | C.R. Bard, Inc. | 2015-11-20 |
| K150733 | Vital-Port Vascular Access System Power Injectable Port | Cook Incorporated | 2015-05-21 |
| K141146 | INVISIPORT | Stealth Therapeutics, Incorporated | 2015-05-01 |
| K140169 | VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM | Cook Incorporated | 2014-05-21 |
| K133335 | POWERPORT IMPLANTABLE PORT | C.R. Bard, Inc. | 2014-02-14 |
| K132177 | MEDCOMP GEN III POWER INJECTABLE PORT | Medcomp ( Medical Components) | 2013-12-12 |