The following data is part of a premarket notification filed by Norton Performance Plastics Corp. with the FDA for Central Venous Catheter W/big-gard.
| Device ID | K841828 |
| 510k Number | K841828 |
| Device Name: | CENTRAL VENOUS CATHETER W/BIG-GARD |
| Classification | Catheter, Percutaneous |
| Applicant | NORTON PERFORMANCE PLASTICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-03 |
| Decision Date | 1984-07-13 |