K940319 is an FDA 510(k) clearance for the R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by R-Group Intl. (Gainesville, US). The FDA issued a Cleared decision on November 10, 1994, 290 days after receiving the submission on January 24, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K940319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 1994 |
| Decision Date | November 10, 1994 |
| Days to Decision | 290 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |