510(k) K091516
K091516 is an FDA 510(k) premarket notification submitted by Well Lead Medical Co., Ltd. for the device "WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR". The FDA issued a decision of Substantially Equivalent on October 16, 2009. The device falls under product code EZL (Catheter, Retention Type, Balloon), 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
- October 16, 2009
- Date Received
- May 22, 2009
- 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