510(k) K905842
- Device
- STRATO PORT INTRODUCER KT(12 FR) LPS 5213/MODIFIED
- Applicant
- STRATO MEDICAL CORP.
- 510(k) number
- K905842
- Product code
- LJT
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 1991-04-19
- Date received
- 1990-12-27
- Regulation
- 880.5965
- Classification name
- Port & Catheter, Implanted, Subcutaneous, Intravascular
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Clearance type
- Traditional
- Third party reviewed
- No
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 |
| K232737 | 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 | Bard Peripheral Vascular, Inc. | 2023-12-08 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases