The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Miniguard Arterial Safety Valve.
| Device ID | K182442 |
| 510k Number | K182442 |
| Device Name: | MiniGuard Arterial Safety Valve |
| Classification | Cpb Check Valve, Retrograde Flow, In-line |
| Applicant | Quest Medical, Inc. One Allentown Parkway Allen, TX 75002 |
| Contact | Tosan Onosode |
| Correspondent | Tosan Onosode Quest Medical, Inc. One Allentown Parkway Allen, TX 75002 |
| Product Code | MJJ |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-07 |
| Decision Date | 2018-11-06 |
| Summary: | summary |