The following data is part of a premarket notification filed by Chase Medical, Inc. with the FDA for Chase Multiple Perfusion Set.
| Device ID | K964200 |
| 510k Number | K964200 |
| Device Name: | CHASE MULTIPLE PERFUSION SET |
| 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 | 1997-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20817278011744 | K964200 | 000 |
| 10817278010740 | K964200 | 000 |
| 10817278010733 | K964200 | 000 |
| 10817278010726 | K964200 | 000 |
| 10817278010368 | K964200 | 000 |
| 10817278010351 | K964200 | 000 |
| 10817278010344 | K964200 | 000 |
| 10817278010337 | K964200 | 000 |
| 10817278010320 | K964200 | 000 |
| 00817278010316 | K964200 | 000 |
| 10817278010306 | K964200 | 000 |
| 10817278010757 | K964200 | 000 |
| 10817278010764 | K964200 | 000 |
| 10817278010771 | K964200 | 000 |
| 20817278011737 | K964200 | 000 |
| 10817278011679 | K964200 | 000 |
| 10817278011105 | K964200 | 000 |
| 10817278011099 | K964200 | 000 |
| 10817278011082 | K964200 | 000 |
| 10817278011075 | K964200 | 000 |
| 20817278011065 | K964200 | 000 |
| 10817278010924 | K964200 | 000 |
| 10817278010900 | K964200 | 000 |
| 10817278010894 | K964200 | 000 |
| 00817278010293 | K964200 | 000 |