The following data is part of a premarket notification filed by Piper Access Llc with the FDA for 5 Fr Dual Lumen Piper Picc.
| Device ID | K181904 |
| 510k Number | K181904 |
| Device Name: | 5 FR Dual Lumen Piper PICC |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | Piper Access LLC 3981 South 700 East Suite 15 Salt Lake City, UT 84107 |
| Contact | Jay Muse |
| Correspondent | Jay Muse Piper Access LLC 3981 South 700 East Suite 15 Salt Lake City, UT 84107 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-16 |
| Decision Date | 2018-09-25 |
| Summary: | summary |