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, a class II device type, regulated under 21 CFR 880.5970. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OMF
- Device name
- Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
- FDA 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.
- Regulation
- 21 CFR 880.5970
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 2
- Ingested recalls
- 0
Clearances, product code OMF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 1 |
Applicants with the most clearances
Product code OMF| Applicant | Clearances |
|---|---|
| Halyard Health | 1 |
| FUJIFILM SonoSite,Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code OMF.
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