The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Nitroglycerin Intravascular Administration Set.
| Device ID | K860157 |
| 510k Number | K860157 |
| Device Name: | NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | QUEST MEDICAL, INC. 3312 WILEY POST RD. Carrollton, TX 75006 |
| Contact | Claude Pering |
| Correspondent | Claude Pering QUEST MEDICAL, INC. 3312 WILEY POST RD. Carrollton, TX 75006 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-16 |
| Decision Date | 1986-04-09 |