The following data is part of a premarket notification filed by Arstasis, Inc. with the FDA for Itg Vascular Access System, Model 300.
| Device ID | K091006 |
| 510k Number | K091006 |
| Device Name: | ITG VASCULAR ACCESS SYSTEM, MODEL 300 |
| Classification | Introducer, Catheter |
| Applicant | ARSTASIS, INC. 1021 HOWARD AVE SUITE C San Carlos, CA 94070 |
| Contact | Dominique Filloux |
| Correspondent | Dominique Filloux ARSTASIS, INC. 1021 HOWARD AVE SUITE C San Carlos, CA 94070 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2009-04-08 |
| Decision Date | 2010-02-25 |
| Summary: | summary |