510(k) K083121
K083121 is an FDA 510(k) premarket notification submitted by Corpak Medsystems for the device "NEO MAPCATH SENSOR STYLET". The FDA issued a decision of Substantially Equivalent on February 11, 2009. The device falls under product code OMF (Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position), a Class II device regulated under 21 CFR 880.5970. Corpak Medsystems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 2009
- Date Received
- October 22, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type
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.