Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
Port and Catheter, Implanted, Subcutaneous, Intraperitoneal is a totally implantable access system consisting of a subcutaneous port connected to a catheter that delivers fluids or drugs directly into the peritoneal cavity, used for intraperitoneal chemotherapy or continuous ambulatory peritoneal dialysis. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LLD, regulated under 21 CFR 880.5965, within the General Hospital medical specialty. This device is an implant.
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Basic Information
- Product Code
- LLD
- Device Class
- FDA class 2
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K880072 | PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM | Mar 29, 1988 | Substantially Equivalent | Pharmacia Deltec, Inc. |
| K864552 | PORT-A-CATH IMPLANTABLE CATHETER SYSTEM | Mar 31, 1987 | Substantially Equivalent | Pharmacia, Inc. |
| K862412 | INTESTOPLANT | Nov 13, 1986 | Substantially Equivalent | Burron Medical Products, Inc. |
| K832906 | PORT-A-CATH IMPLANTABLE CATHETER SYS | Mar 06, 1984 | Substantially Equivalent | Pharmacia, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.