The following data is part of a premarket notification filed by Arstasis, Inc. with the FDA for Microtract Access System.
| Device ID | K151877 |
| 510k Number | K151877 |
| Device Name: | MicroTract Access System |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | ARSTASIS, INC. 6500 KAISER DRIVE SUITE 120 Fremont, CA 94555 |
| Contact | Debra Cogan |
| Correspondent | Debra Cogan ARSTASIS, INC. 6500 KAISER DRIVE SUITE 120 Fremont, CA 94555 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-09 |
| Decision Date | 2015-08-07 |
| Summary: | summary |