The following data is part of a premarket notification filed by Mirador Biomedical, Inc. with the FDA for Compass Vascular Access / Access Port / Lumbar Puncture / Intracranial Pressure.
Device ID | K103715 |
510k Number | K103715 |
Device Name: | COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 300 Seattle, WA 98102 |
Contact | Justin Hulvershorn |
Correspondent | Justin Hulvershorn MIRADOR BIOMEDICAL, INC. 2815 WASTLAKE AVENUE SUITE 300 Seattle, WA 98102 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-21 |
Decision Date | 2011-01-20 |