K925176 is an FDA 510(k) clearance for the VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE. This device is classified as a Catheter, Irrigation (Class I - General Controls, product code GBX).
Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on April 8, 1993, 176 days after receiving the submission on October 14, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K925176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1992 |
| Decision Date | April 08, 1993 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GBX — Catheter, Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |