The following data is part of a premarket notification filed by Chase Medical, Inc. with the FDA for Cahse Aortic Root Cannula.
| Device ID | K964198 |
| 510k Number | K964198 |
| Device Name: | CAHSE AORTIC ROOT CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CHASE MEDICAL, INC. 1876 FIRMAN DR. Richardson, TX 75081 |
| Contact | Bert Davis |
| Correspondent | Bert Davis CHASE MEDICAL, INC. 1876 FIRMAN DR. Richardson, TX 75081 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-21 |
| Decision Date | 1997-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817278012317 | K964198 | 000 |
| 10817278010245 | K964198 | 000 |
| 10817278010252 | K964198 | 000 |
| 00817278010682 | K964198 | 000 |
| 20817278011010 | K964198 | 000 |
| 20817278011027 | K964198 | 000 |
| 20817278011041 | K964198 | 000 |
| 10817278011419 | K964198 | 000 |
| 10817278011426 | K964198 | 000 |
| 10817278011433 | K964198 | 000 |
| 10817278011440 | K964198 | 000 |
| 10817278011761 | K964198 | 000 |
| 10817278011778 | K964198 | 000 |
| 00817278011788 | K964198 | 000 |
| 10817278010238 | K964198 | 000 |