The following data is part of a premarket notification filed by California Medical Laboratories, Inc. with the FDA for Retrograde Cardioplegia Cannula, Manual-inflating, With Malleable Or Guidwire Stylet.
| Device ID | K010974 |
| 510k Number | K010974 |
| Device Name: | RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CALIFORNIA MEDICAL LABORATORIES, INC. 1570 SUNLAND LN. Costa Mesa, CA 92626 |
| Contact | Mehmet Bicakci |
| Correspondent | Mehmet Bicakci CALIFORNIA MEDICAL LABORATORIES, INC. 1570 SUNLAND LN. Costa Mesa, CA 92626 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-02 |
| Decision Date | 2001-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622128186 | K010974 | 000 |
| 10803622105194 | K010974 | 000 |
| 10803622105200 | K010974 | 000 |
| 10803622105217 | K010974 | 000 |
| 10803622105224 | K010974 | 000 |
| 10803622105231 | K010974 | 000 |
| 10803622105248 | K010974 | 000 |
| 10803622128124 | K010974 | 000 |
| 10803622128131 | K010974 | 000 |
| 10803622128148 | K010974 | 000 |
| 10803622128155 | K010974 | 000 |
| 10803622128162 | K010974 | 000 |
| 10803622128179 | K010974 | 000 |
| 10803622105187 | K010974 | 000 |