The following data is part of a premarket notification filed by Chase Medical, Inc. with the FDA for Chare Cariovascular Patch.
| Device ID | K021129 |
| 510k Number | K021129 |
| Device Name: | CHARE CARIOVASCULAR PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | CHASE MEDICAL, INC. 1710 FIRMAN DR. SUITE 100 Richardson, TX 75081 |
| Contact | Dave Hernon |
| Correspondent | Dave Hernon CHASE MEDICAL, INC. 1710 FIRMAN DR. SUITE 100 Richardson, TX 75081 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-08 |
| Decision Date | 2002-06-03 |