K821996 is an FDA 510(k) clearance for the LEONARD PERIPHERAL VENOUS PRESSURE CATH. This device is classified as a Catheter, Flow Directed (Class II - Special Controls, product code DYG).
Submitted by Norton Performance Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1982, 23 days after receiving the submission on July 7, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K821996 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 1982 |
| Decision Date | July 30, 1982 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DYG — Catheter, Flow Directed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1240 |