FDA product code LNY: Catheter, Percutaneous, Long Term, Intraspinal
LNY is the FDA product code for catheter, percutaneous, long term, intraspinal. It is a Class III device, reviewed by the General Hospital panel. Devices under LNY reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 1 recall for LNY devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Percutaneous, Long Term, Intraspinal |
| Device class | Class III |
| Review panel | HO — General Hospital |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LNY devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-03-29.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
Frequently asked questions
What is FDA product code LNY?
LNY is the FDA product code for catheter, percutaneous, long term, intraspinal. It is a Class III device, reviewed by the General Hospital panel.
What device class is LNY?
Class III. Typical premarket route: PMA.
Have LNY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-03-29.
Next steps
- Run an FDA pathway report with predicate devices for product code LNY
- Run a recall and safety report across every LNY manufacturer
- Watch product code LNY 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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