K904734 is an FDA 510(k) clearance for the PHARMASEAL DISPOSABLE ABDOMINAL TROCAR. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on November 21, 1990, 35 days after receiving the submission on October 17, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K904734 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 1990 |
| Decision Date | November 21, 1990 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |