K902109 is an FDA 510(k) clearance for the STATLOCK IV CONNECTOR AND ANCHOR SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Venetec, Inc. (Denver, US). The FDA issued a Cleared decision on October 19, 1990, 163 days after receiving the submission on May 9, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K902109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1990 |
| Decision Date | October 19, 1990 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |