The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Adult Vent Catheter.
| Device ID | K834352 |
| 510k Number | K834352 |
| Device Name: | ADULT VENT CATHETER |
| Classification | Catheter, Steerable |
| Applicant | DLP, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-13 |
| Decision Date | 1984-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169086719 | K834352 | 000 |
| 20643169086702 | K834352 | 000 |
| 20613994540465 | K834352 | 000 |
| 20613994540434 | K834352 | 000 |
| 20613994540359 | K834352 | 000 |