The following data is part of a premarket notification filed by Q'apel with the FDA for 087 Balloon Guide Catheter System.
| Device ID | K190749 |
| 510k Number | K190749 |
| Device Name: | 087 Balloon Guide Catheter System |
| Classification | Catheter, Percutaneous |
| Applicant | Q'Apel 330 Wilshire Boulevard Santa Monica, CA 90401 |
| Contact | Ken Peartree |
| Correspondent | Michele Lucey Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, NH 03255 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-25 |
| Decision Date | 2019-07-15 |