510(k) K181088
K181088 is an FDA 510(k) premarket notification submitted by Transseptal Solutions , Ltd. for the device "TSP Crosser Transseptal Access System". The FDA issued a decision of Substantially Equivalent on Sep 28, 2018. 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
- Sep 28, 2018
- Date Received
- Apr 25, 2018
- 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)