FDA product code LKG: Port & Catheter, Implanted, Subcutaneous, Intraventricular
LKG is the FDA product code for port & catheter, implanted, subcutaneous, intraventricular. It is a Class II device, regulated under 21 CFR 882.5550 and reviewed by the General Hospital panel. FDA has cleared 8 510(k) submissions under LKG, from 5 different applicants. The average 510(k) review took 107 days (median 102).
Classification
| Field | Value |
|---|---|
| Device name | Port & Catheter, Implanted, Subcutaneous, Intraventricular |
| Device class | Class II |
| Regulation | 21 CFR 882.5550 |
| Review panel | HO — General Hospital |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every LKG clearance
Top LKG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pudenz-Schulte Medical Research Corp. | 3 | 1988-02-11 |
| Pharmacia Deltec, Inc. | 2 | 1988-05-20 |
| Cordis Corp. | 1 | 1995-05-09 |
| Holter-Hausner Intl. | 1 | 1984-03-06 |
| American Heyer Schulte | 1 | 1983-04-28 |
Most recent LKG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950315 | Cordis Corp. | CORDIS CSF RESERVOIR | 1995-05-09 | 103 |
| K881493 | Pharmacia Deltec, Inc. | PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. | 1988-05-20 | 42 |
| K881690 | Pharmacia Deltec, Inc. | PORT-A-CATH PORTAL INTRODUCER FORCEPS | 1988-05-20 | 31 |
| K874468 | Pudenz-Schulte Medical Research Corp. | P-S MEDICAL VENTRICULAR ACCESS PORT | 1988-02-11 | 101 |
| K874498 | Pudenz-Schulte Medical Research Corp. | CSF-VENTRICULOSTOMY RESERVOIR | 1988-02-11 | 101 |
Recalls for LKG devices
openFDA lists no recalls for product code LKG.
Frequently asked questions
What is FDA product code LKG?
LKG is the FDA product code for port & catheter, implanted, subcutaneous, intraventricular. It is a Class II device, regulated under 21 CFR 882.5550 and reviewed by the General Hospital panel.
What device class is LKG?
Class II, regulation 21 CFR 882.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKG?
Across 8 cleared submissions the average was 107 days from receipt to decision (median 102).
Which companies have the most LKG clearances?
Pudenz-Schulte Medical Research Corp. (3); Pharmacia Deltec, Inc. (2); Cordis Corp. (1); Holter-Hausner Intl. (1); American Heyer Schulte (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LKG
- Run a recall and safety report across every LKG manufacturer
- Watch product code LKG 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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