The following data is part of a premarket notification filed by Maersk Medical A/s with the FDA for Paradigm Quick-set Infusion Set.
| Device ID | K011071 |
| 510k Number | K011071 |
| Device Name: | PARADIGM QUICK-SET INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MAERSK MEDICAL A/S 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
| Contact | Gerda Resch |
| Correspondent | Gerda Resch MAERSK MEDICAL A/S 18000 DEVONSHIRE ST. Northridge, CA 91325 -1219 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-09 |
| Decision Date | 2001-06-07 |