510(k) K063632
K063632 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER". The FDA issued a decision of Substantially Equivalent on January 5, 2007. The device falls under product code LJE (Catheter, Nephrostomy), a Class U device. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 2007
- Date Received
- December 6, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Nephrostomy
- Device Class
- Class U
- Regulation Number
- Review Panel
- GU
- Submission Type