The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Q2 Low Pressure Power Injection Extension Set.
| Device ID | K162804 |
| 510k Number | K162804 |
| Device Name: | Q2 Low Pressure Power Injection Extension Set |
| Classification | Set, Administration, Intravascular |
| Applicant | QUEST MEDICAL, INC. ONE ALLENTOWN PARKWAY Allen, TX 75002 |
| Contact | Amy Clendening-wheeler |
| Correspondent | Amy Clendening-wheeler QUEST MEDICAL, INC. ONE ALLENTOWN PARKWAY Allen, TX 75002 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-05 |
| Decision Date | 2017-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20634624959075 | K162804 | 000 |
| 20634624959068 | K162804 | 000 |
| 20634624957279 | K162804 | 000 |
| 20634624957262 | K162804 | 000 |
| 20634624957149 | K162804 | 000 |