The following data is part of a premarket notification filed by California Medical Laboratories, Inc. with the FDA for Retrograde Cardioplegia Cannula, Self-inflating, With Malleable Or Guidewire Stylet.
| Device ID | K002019 |
| 510k Number | K002019 |
| Device Name: | RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CALIFORNIA MEDICAL LABORATORIES, INC. 2681 KELVIN AVE. Irvine, CA 92614 |
| Contact | Mehmet Bicakci |
| Correspondent | Mehmet Bicakci CALIFORNIA MEDICAL LABORATORIES, INC. 2681 KELVIN AVE. Irvine, CA 92614 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-03 |
| Decision Date | 2001-03-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622128216 | K002019 | 000 |
| 10803622105262 | K002019 | 000 |
| 10803622105279 | K002019 | 000 |
| 10803622105309 | K002019 | 000 |
| 10803622105316 | K002019 | 000 |
| 10803622105323 | K002019 | 000 |
| 10803622105330 | K002019 | 000 |
| 10803622105347 | K002019 | 000 |
| 10803622105354 | K002019 | 000 |
| 10803622128193 | K002019 | 000 |
| 10803622128209 | K002019 | 000 |
| 10803622105255 | K002019 | 000 |