The following data is part of a premarket notification filed by Access Scientific, Inc. with the FDA for The Picc Wand Peelable Safety Introducer.
| Device ID | K093022 |
| 510k Number | K093022 |
| Device Name: | THE PICC WAND PEELABLE SAFETY INTRODUCER |
| 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 | 2009-09-29 |
| Decision Date | 2010-01-20 |
| Summary: | summary |