510(k) K153461
Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm by
Maquet Critical Care AB
— Product Code KNT
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 2015
- Date Received
- December 1, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type