The following data is part of a premarket notification filed by Piper Access, Llc with the FDA for Stiletto Extended Dwell Catheter.
| Device ID | K210047 |
| 510k Number | K210047 |
| Device Name: | Stiletto Extended Dwell Catheter |
| Classification | Midline Catheter |
| Applicant | Piper Access, LLC 6030 W. Harold Gatty Dr. Salt Lake City, UT 84116 |
| Contact | Jay Muse |
| Correspondent | Jay Muse Piper Access, LLC 6030 W. Harold Gatty Dr. Salt Lake City, UT 84116 |
| Product Code | PND |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-08 |
| Decision Date | 2021-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850051842001 | K210047 | 000 |
| 10850042365059 | K210047 | 000 |