510(k) K121504
K121504 is an FDA 510(k) premarket notification submitted by Togo Medikit Co., Ltd. for the device "SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS". The FDA issued a decision of Substantially Equivalent on September 27, 2012. 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
- September 27, 2012
- Date Received
- May 21, 2012
- Clearance Type
- Traditional
- 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