510(k) K083675
K083675 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER". The FDA issued a decision of Substantially Equivalent on March 19, 2009. The device falls under product code NIE (Catheter, Hemodialysis, Triple Lumen, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2009
- Date Received
- December 11, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Hemodialysis, Triple Lumen, Non-Implanted
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type
Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.