K001874 is an FDA 510(k) clearance for the PERIPHERALLY INSERTED CENTRAL CATHETER. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Utah Medical Products, Inc. (Midvale, US). The FDA issued a Cleared decision on September 25, 2000, 97 days after receiving the submission on June 20, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K001874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2000 |
| Decision Date | September 25, 2000 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |