The following data is part of a premarket notification filed by Nostix Llc with the FDA for Picc Tip Positioning Aid.
| Device ID | K152261 |
| 510k Number | K152261 |
| Device Name: | PICC Tip Positioning Aid |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | NOSTIX LLC 5541 CENTRAL AVE, SUITE 170 Boulder, CO 80301 |
| Contact | Peter Nelson |
| Correspondent | Jim Lewis Salus Ventures LLC 5335 Holmes Place Boulder, CO 80303 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-11 |
| Decision Date | 2015-10-21 |
| Summary: | summary |