The following data is part of a premarket notification filed by California Medical Laboratories, Inc. with the FDA for Cardioplegia Adapters, Vessel Canulae, And Aortic Root Cannulae.
| Device ID | K972503 |
| 510k Number | K972503 |
| Device Name: | CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE |
| 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 | 1997-07-03 |
| Decision Date | 1997-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622128353 | K972503 | 000 |
| 10803622106245 | K972503 | 000 |
| 10803622106238 | K972503 | 000 |
| 10803622106221 | K972503 | 000 |
| 10803622103114 | K972503 | 000 |
| 10803622103091 | K972503 | 000 |
| 10803622103084 | K972503 | 000 |
| 10803622103077 | K972503 | 000 |
| 10803622103060 | K972503 | 000 |
| 10803622103053 | K972503 | 000 |
| 10803622103046 | K972503 | 000 |
| 10803622103039 | K972503 | 000 |
| 10803622103022 | K972503 | 000 |
| 10803622103015 | K972503 | 000 |
| 10803622106252 | K972503 | 000 |
| 10803622106269 | K972503 | 000 |
| 10803622124430 | K972503 | 000 |
| 10803622124423 | K972503 | 000 |
| 10803622112857 | K972503 | 000 |
| 10803622106597 | K972503 | 000 |
| 10803622106580 | K972503 | 000 |
| 10803622106573 | K972503 | 000 |
| 10803622106511 | K972503 | 000 |
| 10803622106504 | K972503 | 000 |
| 10803622106313 | K972503 | 000 |
| 10803622106306 | K972503 | 000 |
| 10803622106290 | K972503 | 000 |
| 10803622106283 | K972503 | 000 |
| 10803622106276 | K972503 | 000 |
| 10803622103008 | K972503 | 000 |