510(k) K063355
K063355 is an FDA 510(k) premarket notification submitted by Novosci Corp. for the device "D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW". The FDA issued a decision of Substantially Equivalent (kit) on July 27, 2007. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Novosci Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- July 27, 2007
- Date Received
- November 7, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Hemodialysis, Non-Implanted
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type