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, 3fr. Model.
| Device ID | K162322 |
| 510k Number | K162322 |
| Device Name: | The POWERWAND Safety Introducer With An Extended Dwell Catheter, 3Fr. Model |
| Classification | Introducer, Catheter |
| Applicant | ACCESS SCIENTIFIC, LLC 3910 Sorrento Valley Blvd Ste 200 San Diego, CA 92121 |
| Contact | Walter Cordiglia |
| Correspondent | Walter Cordiglia ACCESS SCIENTIFIC, LLC 3910 Sorrento Valley Blvd Ste 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 | 2016-08-19 |
| Decision Date | 2016-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859821006674 | K162322 | 000 |