The following data is part of a premarket notification filed by Mirador Biomedical, Inc. with the FDA for Compass Vascular Access; Compass Lumbar Puncture.
| Device ID | K101518 |
| 510k Number | K101518 |
| Device Name: | COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 300 Seattle, WA 98102 |
| Contact | Justin Hulvershorn Md, Phd |
| Correspondent | Justin Hulvershorn Md, Phd MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 300 Seattle, WA 98102 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-02 |
| Decision Date | 2010-10-13 |
| Summary: | summary |