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 |