HDC Chemo-Port (Vascular)
FDA 510(k) K853332 · Hdc Corp.
510(k) numberK853332
Submission
- Device name
- HDC Chemo-Port (Vascular)
- Applicant
- Hdc Corp.
Mountain View, CA, US - Received
- August 8, 1985
- Decision date
- July 17, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K071875 | V-Cath Poly PiccLJS · Traditional | 11/05/2007SE |
| K023342 | Neuro-Trace III Kit, Neuro-Trace III Regional Block Cable, Neuro-Trace III Nerve Mapping…KOI · Traditional | 03/02/2004SE |
| K033853 | Modification to V-Cath Poly PiccFOZ · Special | 01/14/2004SE |
| K032404 | Seldinger Safety Needle IntroducerDYB · Special | 09/10/2003SE |
| K022752 | Pandin Continuous Nerve Stimulating Catheter, Models 561-18-05, 561-18-09, 561-18-15…CAZ · Traditional | 09/09/2003SE |
| K022099 | Safe-T-Peel Safety Needle/Introducer, Models 350-300 S, 360-300'S,380-300'S,390-300'SFOZ · Traditional | 09/20/2002SE |
| K010425 | Epidural Catheter with Connector (and Accessory)KNF · Special | 03/15/2001SE |
| K994059 | Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07CAZ · Traditional | 10/13/2000SE |
| K002770 | Ibis Chemo-Port Implantable Vascular Access System, Model…LJT · Special | 09/26/2000SE |
| K983119 | Entero-Test HP, Model #102-01LIO · Traditional | 03/15/1999SE |
Questions and answers
When was HDC Chemo-Port (Vascular) cleared by the FDA?
HDC Chemo-Port (Vascular) (K853332) received a 510(k) decision of Substantially Equivalent on July 17, 1986, 343 days after the submission was received.
What is the product code of K853332?
The FDA product code is LJT – Port & Catheter, Implanted, Subcutaneous, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5965.