The following data is part of a premarket notification filed by Q'apel Medical Inc with the FDA for Selectflex Neurovascular Access System Family.
| Device ID | K211893 |
| 510k Number | K211893 |
| Device Name: | SelectFlex Neurovascular Access System Family |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Q'Apel Medical Inc 46708 Lakeview Boulevard Fremont, AR 94538 |
| Contact | Ken Peartree |
| Correspondent | Michele Lucey Lakeshore Medical Device Consulting 128 Blye HIll Landing Newbury, NH 03255 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2021-08-05 |