The following data is part of a premarket notification filed by Arstasis, Inc. with the FDA for Arstasis Access System.
| Device ID | K100615 |
| 510k Number | K100615 |
| Device Name: | ARSTASIS ACCESS SYSTEM |
| Classification | Introducer, Catheter |
| Applicant | ARSTASIS, INC. 1021 HOWARD AVE SUITE C San Carlos, CA 94070 |
| Contact | Su-mien Chong |
| Correspondent | Su-mien Chong ARSTASIS, INC. 1021 HOWARD AVE SUITE C San Carlos, CA 94070 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-04 |
| Decision Date | 2010-03-30 |
| Summary: | summary |