The following data is part of a premarket notification filed by Sentreheart Inc. with the FDA for Lariat Ii Suture Delivery Device.
| Device ID | K090385 |
| 510k Number | K090385 |
| Device Name: | LARIAT II SUTURE DELIVERY DEVICE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SENTREHEART INC. 2468 EMBARCADERO WAY Palo Alto, CA 94303 |
| Contact | Linda Guthrie |
| Correspondent | Linda Guthrie SENTREHEART INC. 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 | 2009-02-17 |
| Decision Date | 2009-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818354017601 | K090385 | 000 |
| 30840143901809 | K090385 | 000 |
| 30840143903698 | K090385 | 000 |
| 30840143909645 | K090385 | 000 |