The following data is part of a premarket notification filed by Coapt Systems, Inc. with the FDA for Coapt Systmes Endotine Device.
| Device ID | K014153 |
| 510k Number | K014153 |
| Device Name: | COAPT SYSTMES ENDOTINE DEVICE |
| Classification | Screw, Fixation, Bone |
| Applicant | COAPT SYSTEMS, INC. 261 HAMILTON AVE. SUITE 413 Palo Alto, CA 94301 |
| Contact | Jude Paganelli |
| Correspondent | Jude Paganelli COAPT SYSTEMS, INC. 261 HAMILTON AVE. SUITE 413 Palo Alto, CA 94301 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-18 |
| Decision Date | 2002-03-15 |
| Summary: | summary |