The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Infant Vent Catheter 12001 W/side Vent.
| Device ID | K834039 |
| 510k Number | K834039 |
| Device Name: | INFANT VENT CATHETER 12001 W/SIDE VENT |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-23 |
| Decision Date | 1984-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169112544 | K834039 | 000 |
| 20643169086733 | K834039 | 000 |
| 20643169081912 | K834039 | 000 |
| 20643169081905 | K834039 | 000 |
| 20643169081899 | K834039 | 000 |
| 20643169081882 | K834039 | 000 |
| 20643169880935 | K834039 | 000 |
| 00763000946432 | K834039 | 000 |
| 00763000946418 | K834039 | 000 |
| 00763000946425 | K834039 | 000 |
| 20643169086740 | K834039 | 000 |
| 20643169878680 | K834039 | 000 |
| 00643169112537 | K834039 | 000 |
| 00643169112520 | K834039 | 000 |
| 00643169112513 | K834039 | 000 |
| 00643169969285 | K834039 | 000 |
| 00643169695962 | K834039 | 000 |
| 20643169881338 | K834039 | 000 |
| 20643169880676 | K834039 | 000 |
| 20643169880669 | K834039 | 000 |
| 20643169878697 | K834039 | 000 |
| 00763000946401 | K834039 | 000 |