The following data is part of a premarket notification filed by Minimed, Inc. with the FDA for Paradigm Sof-set Ultimate Qr, Models 317 And 318.
| Device ID | K001832 |
| 510k Number | K001832 |
| Device Name: | PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318 |
| Classification | Set, Administration, Intravascular |
| Applicant | MINIMED, INC. 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Jennifer Lyons |
| Correspondent | Jennifer Lyons MINIMED, INC. 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-16 |
| Decision Date | 2000-08-18 |