K011928 is an FDA 510(k) clearance for the HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on August 10, 2001, 51 days after receiving the submission on June 20, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K011928 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2001 |
| Decision Date | August 10, 2001 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |