The following data is part of a premarket notification filed by Inneuroco, Inc with the FDA for 091 Long Sheath, 70 Cm, 091 Long Sheath, 80 Cm, 091 Long Sheath, 90 Cm.
| Device ID | K172468 |
| 510k Number | K172468 |
| Device Name: | 091 Long Sheath, 70 Cm, 091 Long Sheath, 80 Cm, 091 Long Sheath, 90 Cm |
| Classification | Catheter, Percutaneous |
| Applicant | InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, FL 33351 |
| Contact | Marc Litzenberg |
| Correspondent | Marianne Grunwaldt InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, FL 33351 |
| Product Code | DQY |
| Subsequent Product Code | DTL |
| Subsequent Product Code | GCC |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-15 |
| Decision Date | 2017-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327459203 | K172468 | 000 |
| 07613327459197 | K172468 | 000 |
| 07613327459180 | K172468 | 000 |