510(k) K013276
K013276 is an FDA 510(k) premarket notification submitted by Sewoon Medical Co., Ltd. for the device "ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE)". The FDA issued a decision of Substantially Equivalent on Feb 15, 2002. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 15, 2002
- Date Received
- Oct 1, 2001
- 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)