The following data is part of a premarket notification filed by Access Scientific, Inc. with the FDA for The Powerwand Safety Introducer With And Extended Dwell.
| Device ID | K121748 |
| 510k Number | K121748 |
| Device Name: | THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-14 |
| Decision Date | 2012-07-27 |
| Summary: | summary |