FDA product code LLD: Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
LLD is the FDA product code for port & catheter, implanted, subcutaneous, intraperitoneal. It is a Class II device, regulated under 21 CFR 880.5965 and reviewed by the General Hospital panel. FDA has cleared 4 510(k) submissions under LLD, from 3 different applicants. The average 510(k) review took 135 days (median 136). FDA has posted 6 recalls for LLD devices.
Classification
| Field | Value |
|---|---|
| Device name | Port & Catheter, Implanted, Subcutaneous, Intraperitoneal |
| Device class | Class II |
| Regulation | 21 CFR 880.5965 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LLD clearance
Top LLD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pharmacia, Inc. | 2 | 1987-03-31 |
| Pharmacia Deltec, Inc. | 1 | 1988-03-29 |
| Burron Medical Products, Inc. | 1 | 1986-11-13 |
Most recent LLD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880072 | Pharmacia Deltec, Inc. | PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM | 1988-03-29 | 78 |
| K864552 | Pharmacia, Inc. | PORT-A-CATH IMPLANTABLE CATHETER SYSTEM | 1987-03-31 | 132 |
| K862412 | Burron Medical Products, Inc. | INTESTOPLANT | 1986-11-13 | 141 |
| K832906 | Pharmacia, Inc. | PORT-A-CATH IMPLANTABLE CATHETER SYS | 1984-03-06 | 190 |
Recalls for LLD devices
6 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-06-08.
Frequently asked questions
What is FDA product code LLD?
LLD is the FDA product code for port & catheter, implanted, subcutaneous, intraperitoneal. It is a Class II device, regulated under 21 CFR 880.5965 and reviewed by the General Hospital panel.
What device class is LLD?
Class II, regulation 21 CFR 880.5965. Typical premarket route: 510(k).
How long does a 510(k) take for product code LLD?
Across 4 cleared submissions the average was 135 days from receipt to decision (median 136).
Which companies have the most LLD clearances?
Pharmacia, Inc. (2); Pharmacia Deltec, Inc. (1); Burron Medical Products, Inc. (1).
Have LLD devices been recalled?
Yes: 6 product recalls across 2 recall events; the most recent began 2005-06-08.
Next steps
- Run an FDA pathway report with predicate devices for product code LLD
- Run a recall and safety report across every LLD manufacturer
- Watch product code LLD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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