K841828 is an FDA 510(k) clearance for the CENTRAL VENOUS CATHETER W/BIG-GARD. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Norton Performance Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on July 13, 1984, 71 days after receiving the submission on May 3, 1984.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K841828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1984 |
| Decision Date | July 13, 1984 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |