K033576 is an FDA 510(k) clearance for the LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 4, 2003, 21 days after receiving the submission on November 13, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K033576 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2003 |
| Decision Date | December 04, 2003 |
| Days to Decision | 21 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 |