K153469 is an FDA 510(k) clearance for the Cathtong I PICC 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 L&Z Us, Inc. (Fort Lee, US). The FDA issued a Cleared decision on September 1, 2016, 275 days after receiving the submission on December 1, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K153469 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2015 |
| Decision Date | September 01, 2016 |
| Days to Decision | 275 days |
| Submission Type | Special |
| 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 |