510(k) K060190
K060190 is an FDA 510(k) premarket notification submitted by Togo Medikit Co., Ltd. for the device "SUPER SHEATH XL INTRODUCER SHEATH". The FDA issued a decision of Substantially Equivalent on April 4, 2006. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Togo Medikit Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 2006
- Date Received
- January 24, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type