The following data is part of a premarket notification filed by L&z Us, Inc. with the FDA for Cathtong I Picc Catheter.
| Device ID | K153469 |
| 510k Number | K153469 |
| Device Name: | Cathtong I PICC Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | L&Z US, INC. 6 HORIZON ROAD, #2301 Fort Lee, NJ 07024 |
| Contact | Jenella Coutts |
| Correspondent | Jenella Coutts L&Z US, INC. 6 HORIZON ROAD, #2301 Fort Lee, NJ 07024 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-01 |
| Decision Date | 2016-09-01 |
| Summary: | summary |