510(k) K133615
K133615 is an FDA 510(k) premarket notification submitted by Well Lead Medical Co., Ltd. for the device "WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER". The FDA issued a decision of Substantially Equivalent on February 24, 2014. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Well Lead Medical Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2014
- Date Received
- November 25, 2013
- 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