The following data is part of a premarket notification filed by Arstasis, Inc. with the FDA for Arstasis Dilator Adapter.
| Device ID | K103421 |
| 510k Number | K103421 |
| Device Name: | ARSTASIS DILATOR ADAPTER |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | ARSTASIS, INC. 1021 HOWARD AVE SUITE C San Carlos, CA 94070 |
| Contact | Debra Cogan |
| Correspondent | Debra Cogan ARSTASIS, INC. 1021 HOWARD AVE SUITE C San Carlos, CA 94070 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-22 |
| Decision Date | 2011-05-24 |
| Summary: | summary |