The following data is part of a premarket notification filed by Inneuroco, Inc with the FDA for Super Distal Access (sda).
| Device ID | K161262 |
| 510k Number | K161262 |
| Device Name: | Super Distal Access (SDA) |
| Classification | Catheter, Percutaneous |
| Applicant | INNEUROCO, INC 4635 NW 103RD AVENUE Sunrise, FL 33351 |
| Contact | Marc Litzenberg |
| Correspondent | Marianne Grunwaldt INNEUROCO 4635 NW 103RD AVENU Sunrise, FL 33351 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-05 |
| Decision Date | 2016-09-19 |
| Summary: | summary |