The following data is part of a premarket notification filed by Access Scientific, Inc. with the FDA for The Power Wand Safety Introducer With An Extended Dwell Catheter.
| Device ID | K101422 |
| 510k Number | K101422 |
| Device Name: | THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER |
| Classification | Introducer, Catheter |
| Applicant | ACCESS SCIENTIFIC, INC. 12526 HIGH BLUFF DRIVE SUITE 360 San Diego, CA 92130 |
| Contact | Albert Misajon |
| Correspondent | Albert Misajon ACCESS SCIENTIFIC, INC. 12526 HIGH BLUFF DRIVE SUITE 360 San Diego, CA 92130 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-20 |
| Decision Date | 2011-03-22 |
| Summary: | summary |