The following data is part of a premarket notification filed by Arc Surgical Llc. with the FDA for V-guide For Ventriculostomies.
| Device ID | K141559 |
| 510k Number | K141559 |
| Device Name: | V-GUIDE FOR VENTRICULOSTOMIES |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | ARC SURGICAL LLC. 1135 W NASA BLVD STE 500 Melbourne, FL 32901 |
| Contact | Craig Pagan |
| Correspondent | Craig Pagan ARC SURGICAL LLC. 1135 W NASA BLVD STE 500 Melbourne, FL 32901 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-12 |
| Decision Date | 2015-02-27 |
| Summary: | summary |