510(k) K180781
K180781 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Bard Vertus Foley Catheter". The FDA issued a decision of Substantially Equivalent on Sep 19, 2018. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. C.R. Bard, Inc. has 645 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 19, 2018
- Date Received
- Mar 26, 2018
- 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
- 510(k)