510(k) K053589
K053589 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING". The FDA issued a decision of Substantially Equivalent on April 13, 2006. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2006
- Date Received
- December 23, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Hemodialysis, Implanted
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type