Celsite(Tm) Dual Venous System
FDA 510(k) K945551 · B. Braun of America, Inc.
510(k) numberK945551
Submission
- Device name
- Celsite(Tm) Dual Venous System
- Applicant
- B. Braun of America, Inc.
Bethlehem, PA, US - Received
- November 14, 1994
- Decision date
- April 21, 1995
- 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 |
|---|---|---|
| K993024 | Celsite Implantable Port with Valved CatheterLJT · Traditional | 03/13/2000SE |
| K983794 | Chemo Mini Spike PlusLHI · Traditional | 03/23/1999SE |
| K946170 | Comfort-Q Subcutaneous Injection SetsFOZ · Traditional | 11/03/1995SE |
| K945850 | Braun Diacan(R) Fistula NeedlesFIE · Traditional | 10/06/1995SE |
| K942988 | Filtered Extension SetsFPA · Traditional | 07/14/1995SE |
| K945752 | Celsite(Tm) Brachial Venous PortLJT · Traditional | 05/31/1995SE |
| K943770 | Low Volume MultiportFPA · Traditional | 04/10/1995SE |
| K950982 | B. Braun Sonocan Biopsy Needle and Aspiration HandleFCG · Traditional | 04/04/1995SE |
| K950184 | B. Braun IV Start KitsLRS · Traditional | 03/15/1995SEKD |
| K943181 | Dispensing Pin with One-Way ValveLHI · Traditional | 09/29/1994SE |
Questions and answers
When was Celsite(Tm) Dual Venous System cleared by the FDA?
Celsite(Tm) Dual Venous System (K945551) received a 510(k) decision of Substantially Equivalent on April 21, 1995, 158 days after the submission was received.
What is the product code of K945551?
The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.