K011858 is an FDA 510(k) clearance for the INTERLINK THREADED LOCK CANNULA. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on June 19, 2001, 5 days after receiving the submission on June 14, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K011858 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 2001 |
| Decision Date | June 19, 2001 |
| Days to Decision | 5 days |
| Submission Type | Special |
| 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 |