The following data is part of a premarket notification filed by L&z Us, Inc. with the FDA for Cathtong Ii Picc Catheter.
| Device ID | K172039 |
| 510k Number | K172039 |
| Device Name: | CATHTONG II PICC Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | L&Z US, Inc. 6 Horizon Road Fort Lee, NJ 07024 |
| Contact | Jenella Coutts |
| Correspondent | Jenella Coutts L&Z US, Inc. 6 Horizon Road 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 | 2017-07-05 |
| Decision Date | 2017-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861744000158 | K172039 | 000 |