510(k) K984084
K984084 is an FDA 510(k) premarket notification submitted by Bard Medical Div. for the device "BARDEX LUBRI-SIL FOLEY CATHETER". The FDA issued a decision of Substantially Equivalent on February 1, 1999. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Bard Medical Div. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1999
- Date Received
- November 16, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Retention Type, Balloon
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type