510(k) K052557
K052557 is an FDA 510(k) premarket notification submitted by Togo Medikit Co., Ltd. for the device "SUPER SHEATH INTRODUCER SHEATH". The FDA issued a decision of Substantially Equivalent on January 17, 2006. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Togo Medikit Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2006
- Date Received
- September 16, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, For Percutaneous Catheterization
- Device Class
- Class II
- Regulation Number
- 870.1310
- Review Panel
- CV
- Submission Type