K922567 is an FDA 510(k) clearance for the LOW PROFILE CATHETER. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Rusch, Inc. (Jeffrey, US). The FDA issued a Cleared decision on November 21, 1995, 1268 days after receiving the submission on June 1, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K922567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | June 01, 1992 |
| Decision Date | November 21, 1995 |
| Days to Decision | 1268 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNT — Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |