The following data is part of a premarket notification filed by Arkis Biosciences Inc. with the FDA for Sureflo Evd Catheter.
| Device ID | K170599 |
| 510k Number | K170599 |
| Device Name: | SureFlo EVD Catheter |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Arkis BioSciences Inc. 1059 N. Cedar BluffRD #157 Knoxville, TN 37923 |
| Contact | Joseph Howell |
| Correspondent | Joseph Howell Arkis BioSciences Inc. 1059 N. Cedar BluffRD #157 Knoxville, TN 37923 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-01 |
| Decision Date | 2017-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00381780530131 | K170599 | 000 |
| 10381780530138 | K170599 | 000 |
| 10866614000105 | K170599 | 000 |
| 00866614000108 | K170599 | 000 |