Power Port-A-Cath, Cath II, and P.A.S. Port T2 Power P.A.C. Implantable Venous Access Systems and Power Gripper Plus
FDA 510(k) K072657 · Smiths Medical MD, Inc.
510(k) numberK072657
Submission
- Device name
- Power Port-A-Cath, Cath II, and P.A.S. Port T2 Power P.A.C. Implantable Venous Access Systems and Power Gripper Plus
- Applicant
- Smiths Medical MD, Inc.
St. Paul, MN, US - Received
- September 20, 2007
- Decision date
- December 14, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5965
- Specialty
- General Hospital
- Implant
- Yes
Other 510(k)s with product code LJT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260916 | FLEXI-PORT Power Injectable Implantable PortLJT · Traditional | Portal Access, Inc. | 06/17/2026SE |
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable…LJT · Special | Bard Access Systems, Inc. | 09/05/2025SE |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. …LJT · Special | Bard Access Systems, Inc. | 06/18/2025SE |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable…LJT · Special | Bard Access Systems, Inc. | 10/31/2024SE |
| K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG…LJT · Special | Bard Peripheral Vascular, Inc. | 12/08/2023SE |
| K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsLJT · Traditional | AngioDynamics, Inc. | 05/22/2020SE |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®)LJT · Traditional | C.R. Bard, Inc. | 07/08/2019SE |
| K151239 | Nmi Dual Port IILJT · Traditional | Navilyst Medical, Inc. | 06/06/2016SE |
| K153359 | BardPort®, SlimPort®, and X-Port® Implanted PortsLJT · Special | C.R. Bard, Inc. | 05/20/2016SE |
| K153238 | Dignity Dual PortLJT · Traditional | Medcomp ( Medical Components) | 03/15/2016SE |
More from Medcomp ( Medical Components)
| 510(k) | Device | Decision |
|---|---|---|
| K112407 | Smith Medical Peel-Away Sheath IntroducersDYB · Traditional | 02/09/2012SE |
| K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety…FRN · Traditional | 08/29/2011SE |
| K101180 | Gripper Micro Blunt Cannula, Non-Coring Safety Needle (Gripper Micro Needle) Model:…FPA · Traditional | 08/03/2010SE |
| K091181 | Lockbox for Use with Medfusion 3000 Series PumpsMRZ · Traditional | 06/12/2009SE |
| K082783 | Cadd -Solis Medication Safety Software: Administrator and Point-Of-CareMRZ · Traditional | 12/17/2008SE |
| K081156 | Cadd Medication Cassette ReservoirFPA · Traditional | 07/18/2008SE |
| K080743 | Lockbox for Use with Cadd Solis Infusion PumpFRN · Traditional | 04/25/2008SE |
| K072144 | Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software -…MEA · Traditional | 03/07/2008SE |
| K072955 | Cadd-Sentry Pro Medication Safety Software-Administrator (21-6275), Point of Care…MRZ · Traditional | 02/13/2008SE |
| K072059 | Gripper Micro NeedleFMI · Traditional | 11/01/2007SE |
Questions and answers
When was Power Port-A-Cath, Cath II, and P.A.S. Port T2 Power P.A.C. Implantable Venous Access Systems and Power Gripper Plus cleared by the FDA?
Power Port-A-Cath, Cath II, and P.A.S. Port T2 Power P.A.C. Implantable Venous Access Systems and Power Gripper Plus (K072657) received a 510(k) decision of Substantially Equivalent on December 14, 2007, 85 days after the submission was received.
What is the product code of K072657?
The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.