The following data is part of a premarket notification filed by Access Scientific, Llc with the FDA for The Powerwand Safety Introducer With An Extended Dwell Catheter Made Of Chronoflex C® With Bioguard™ Technology-3 Fr, 4 Fr, And 5 Fr Model.
| Device ID | K183066 |
| 510k Number | K183066 |
| Device Name: | The POWERWAND Safety Introducer With An Extended Dwell Catheter Made Of ChronoFlex C® With BioGUARD™ Technology-3 Fr, 4 Fr, And 5 Fr Model |
| Classification | Introducer, Catheter |
| Applicant | Access Scientific, LLC 3910 Sorrento Valley Boulevard, Suite 200 San Diego, CA 92121 |
| Contact | Martina Nguyen |
| Correspondent | Martina Nguyen Access Scientific, LLC 3910 Sorrento Valley Boulevard, Suite 200 San Diego, CA 92121 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-05 |
| Decision Date | 2019-07-25 |
| Summary: | summary |