FDA product code OMF: Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
OMF is the FDA product code for percutaneous, implanted, long-term intravascular catheter accessory for catheter position. It is a Class II device, regulated under 21 CFR 880.5970 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under OMF, from 2 different applicants. The average 510(k) review took 198 days (median 198).
Definition
When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.
Classification
| Field | Value |
|---|---|
| Device name | Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position |
| Device class | Class II |
| Regulation | 21 CFR 880.5970 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every OMF clearance
Top OMF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sonosite,Inc. | 1 | 2010-08-23 |
| Corpak Medsystems | 1 | 2009-02-11 |
Most recent OMF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093510 | Sonosite,Inc. | LUMENVU CATHETER GUIDANCE SYSTEM | 2010-08-23 | 284 |
| K083121 | Corpak Medsystems | NEO MAPCATH SENSOR STYLET | 2009-02-11 | 112 |
Recalls for OMF devices
openFDA lists no recalls for product code OMF.
Frequently asked questions
What is FDA product code OMF?
OMF is the FDA product code for percutaneous, implanted, long-term intravascular catheter accessory for catheter position. It is a Class II device, regulated under 21 CFR 880.5970 and reviewed by the General Hospital panel.
What device class is OMF?
Class II, regulation 21 CFR 880.5970. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMF?
Across 2 cleared submissions the average was 198 days from receipt to decision (median 198).
Which companies have the most OMF clearances?
Sonosite,Inc. (1); Corpak Medsystems (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OMF
- Run a recall and safety report across every OMF manufacturer
- Watch product code OMF 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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