The following data is part of a premarket notification filed by Chase Medical, Inc. with the FDA for Chase Retrograde Cardioplegia Cannula.
| Device ID | K964393 |
| 510k Number | K964393 |
| Device Name: | CHASE RETROGRADE CARDIOPLEGIA 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 | 1996-11-04 |
| Decision Date | 1997-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817278011539 | K964393 | 000 |
| 10817278010481 | K964393 | 000 |
| 10817278010719 | K964393 | 000 |
| 10817278010818 | K964393 | 000 |
| 10817278010825 | K964393 | 000 |
| 10817278010832 | K964393 | 000 |
| 10817278010856 | K964393 | 000 |
| 10817278010863 | K964393 | 000 |
| 10817278010931 | K964393 | 000 |
| 10817278011365 | K964393 | 000 |
| 10817278011372 | K964393 | 000 |
| 10817278011532 | K964393 | 000 |
| 10817278011549 | K964393 | 000 |
| 10817278011556 | K964393 | 000 |
| 10817278011600 | K964393 | 000 |
| 10817278011617 | K964393 | 000 |
| 10817278011624 | K964393 | 000 |
| 10817278011907 | K964393 | 000 |
| 10817278010474 | K964393 | 000 |