510(k) K040658
K040658 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARDEX I.C. LATEX FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on September 29, 2004. The device falls under product code MJC (Catheter, Urological (Antimicrobial) And Accessories), a Class II device regulated under 21 CFR 876.5130. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2004
- Date Received
- March 12, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Urological (Antimicrobial) And Accessories
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type