510(k) K070879
K070879 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD MALECOT AND PEZZER DRAINS". The FDA issued a decision of Substantially Equivalent on April 24, 2007. The device falls under product code FEW (Catheter, Malecot), a Class II device regulated under 21 CFR 876.5090. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 24, 2007
- Date Received
- March 30, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Malecot
- Device Class
- Class II
- Regulation Number
- 876.5090
- Review Panel
- GU
- Submission Type