510(k) K202226
K202226 is an FDA 510(k) premarket notification submitted by Keystone Heart, Ltd. for the device "Lim Precision Steerable TS, Steerable Sheath, Dilator". The FDA issued a decision of Substantially Equivalent on Dec 15, 2020. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 15, 2020
- Date Received
- Aug 7, 2020
- 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
- 510(k)