The following data is part of a premarket notification filed by Sentreheart with the FDA for Lariat Loop Applicator.
| Device ID | K060721 |
| 510k Number | K060721 |
| Device Name: | LARIAT LOOP APPLICATOR |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SENTREHEART 2468 EMBARCADERO WAY Palo Alto, CA 94303 |
| Contact | Robert Chin |
| Correspondent | Robert Chin SENTREHEART 2468 EMBARCADERO WAY Palo Alto, CA 94303 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-17 |
| Decision Date | 2006-06-02 |
| Summary: | summary |