The following data is part of a premarket notification filed by Arch Catheter, Llc with the FDA for Gatekeeper Balloon Catheter.
| Device ID | K192786 |
| 510k Number | K192786 |
| Device Name: | Gatekeeper Balloon Catheter |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | Arch Catheter, LLC 621 Grand Harbor Boulevard Ninety Six, SC 29666 |
| Contact | Michael Zhadkevich |
| Correspondent | Mary Vater Medical Device Academy 345 Lincoln Hill Rd. Shrewsbury, VT 05738 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-04-25 |