K900188 is an FDA 510(k) clearance for the ADVANCE ADMINISTRATION SETS (VARYING LENGTH). This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on May 1, 1990, 105 days after receiving the submission on January 16, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K900188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1990 |
| Decision Date | May 01, 1990 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |