K120008 is an FDA 510(k) clearance for the MEDLINE HIGH PRESSURE INJECTION TUBING. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on August 17, 2012, 227 days after receiving the submission on January 3, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K120008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2012 |
| Decision Date | August 17, 2012 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |