510(k) K172247
K172247 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Magic3 Go Intermittent Urinary Catheter". The FDA issued a decision of Substantially Equivalent on Sep 20, 2017. The device falls under product code EZD (Catheter, Straight), 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 20, 2017
- Date Received
- Jul 26, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type
- 510(k)