K863982 is an FDA 510(k) clearance for the VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY. This device is classified as a Catheter, Infusion (Class I - General Controls, product code JCY).
Submitted by Vas-Cath of Canada , Ltd. (Ontario, L5a 3v3, CA). The FDA issued a Cleared decision on October 24, 1986, 10 days after receiving the submission on October 14, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K863982 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1986 |
| Decision Date | October 24, 1986 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | JCY — Catheter, Infusion |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |