The following data is part of a premarket notification filed by Chase Medical, Inc. with the FDA for Chase Left Vent Safety Valve.
| Device ID | K964391 |
| 510k Number | K964391 |
| Device Name: | CHASE LEFT VENT SAFETY VALVE |
| 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 | 1997-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817278012662 | K964391 | 000 |
| 10817278011266 | K964391 | 000 |
| 00817278010491 | K964391 | 000 |