The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Critikon Triple-lumen Central Venous.
| Device ID | K842316 |
| 510k Number | K842316 |
| Device Name: | CRITIKON TRIPLE-LUMEN CENTRAL VENOUS |
| Classification | Catheter, Percutaneous |
| Applicant | CRITIKON COMPANY,LLC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-12 |
| Decision Date | 1984-07-20 |