The following data is part of a premarket notification filed by Sentreheart Inc. with the FDA for Lariat Sulture Delivery Device.
| Device ID | K142241 |
| 510k Number | K142241 |
| Device Name: | LARIAT Sulture Delivery Device |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SENTREHEART INC. 300 SAGINAW DR Redwood City, CA 94063 -0000 |
| Contact | Kit Cariquitan |
| Correspondent | Kit Cariquitan SENTREHEART INC. 300 SAGINAW DR Redwood City, CA 94063 -0000 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-13 |
| Decision Date | 2014-09-12 |
| Summary: | summary |