510(k) K153096
K153096 is an FDA 510(k) premarket notification submitted by Sentreheart, Inc. for the device "LARIAT RS Suture Delivery Device". The FDA issued a decision of Substantially Equivalent on November 25, 2015. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Sentreheart, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 2015
- Date Received
- October 26, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type