The following data is part of a premarket notification filed by Sentreheart, Inc. with the FDA for Lariat Rs Suture Delivery Device.
| Device ID | K153096 |
| 510k Number | K153096 |
| Device Name: | LARIAT RS Suture Delivery Device |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SentreHEART, Inc. 300 Saginaw Drive Redwood City, CA 94063 |
| Contact | Kit Cariquitan |
| Correspondent | Kit Cariquitan SentreHEART, Inc. 300 Saginaw Drive Redwood City, CA 94063 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-26 |
| Decision Date | 2015-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818354017557 | K153096 | 000 |
| 30840143901724 | K153096 | 000 |
| 30840143903742 | K153096 | 000 |
| 30840143909447 | K153096 | 000 |