K851048 is an FDA 510(k) clearance for the CHEST CATHETERS/THORACIC CATHETERS. This device is classified as a Catheter, Ventricular, General & Plastic Surgery (Class I - General Controls, product code GBS).
Submitted by Medovations, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on June 5, 1985, 83 days after receiving the submission on March 14, 1985.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K851048 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1985 |
| Decision Date | June 05, 1985 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GBS — Catheter, Ventricular, General & Plastic Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |