510(k) K910196
K910196 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS". The FDA issued a decision of Substantially Equivalent on March 27, 1991. The device falls under product code FGH (Catheter, Double Lumen Female Urethrographic), 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
- March 27, 1991
- Date Received
- January 16, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Double Lumen Female Urethrographic
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type