510(k) K170668
K170668 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "HeartSpan Steerable Sheath Introducer". The FDA issued a decision of Substantially Equivalent on Apr 5, 2017. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Merit Medical Systems, Inc. has 180 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 5, 2017
- Date Received
- Mar 6, 2017
- 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
- 510(k)