The following data is part of a premarket notification filed by California Medical Laboratories, Inc. with the FDA for California Medical Laboratories Inc. Malleable Vent Catheter.
| Device ID | K981601 |
| 510k Number | K981601 |
| Device Name: | CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER |
| 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 | 1998-05-04 |
| Decision Date | 1998-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622106498 | K981601 | 000 |
| 10803622106337 | K981601 | 000 |
| 10803622106344 | K981601 | 000 |
| 10803622106351 | K981601 | 000 |
| 10803622106368 | K981601 | 000 |
| 10803622106375 | K981601 | 000 |
| 10803622106382 | K981601 | 000 |
| 10803622106399 | K981601 | 000 |
| 10803622106405 | K981601 | 000 |
| 10803622106412 | K981601 | 000 |
| 10803622106429 | K981601 | 000 |
| 10803622106436 | K981601 | 000 |
| 10803622106443 | K981601 | 000 |
| 10803622106450 | K981601 | 000 |
| 10803622106467 | K981601 | 000 |
| 10803622106474 | K981601 | 000 |
| 10803622106481 | K981601 | 000 |
| 10803622106320 | K981601 | 000 |