K001616 is an FDA 510(k) clearance for the MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE. This device is classified as a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II - Special Controls, product code FOZ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 27, 2000, 63 days after receiving the submission on May 25, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K001616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2000 |
| Decision Date | July 27, 2000 |
| Days to Decision | 63 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |