The following data is part of a premarket notification filed by Inneuroco Inc. with the FDA for 091 Balloon Guide Catheter.
| Device ID | K220331 |
| 510k Number | K220331 |
| Device Name: | 091 Balloon Guide Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | InNeuroCo Inc. 19700 Stirling Road, Suite 1 Pembroke Pines, FL 33332 |
| Contact | Marc Litzenberg |
| Correspondent | Garry Koroshec InNeuroCo Inc. 19700 Stirling Road, Suite 1 Pembroke Pines, FL 33332 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-04 |
| Decision Date | 2022-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08600092100040 | K220331 | 000 |