The following data is part of a premarket notification filed by Maersk Medical A/s with the FDA for Paradigm Silhouette, Models Mmt-377, 378, 379, 380.
| Device ID | K002138 |
| 510k Number | K002138 |
| Device Name: | PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 |
| Classification | Set, Administration, Intravascular |
| Applicant | MAERSK MEDICAL A/S 12744 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Jennifer Lyons |
| Correspondent | Jennifer Lyons MAERSK MEDICAL A/S 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 | 2000-07-17 |
| Decision Date | 2000-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05705244009332 | K002138 | 000 |
| 05705244005235 | K002138 | 000 |
| 05705244005259 | K002138 | 000 |
| 05705244005273 | K002138 | 000 |
| 05705244008410 | K002138 | 000 |
| 05705244008434 | K002138 | 000 |
| 05705244008564 | K002138 | 000 |
| 05705244008588 | K002138 | 000 |
| 05705244008731 | K002138 | 000 |
| 05705244008755 | K002138 | 000 |
| 05705244008878 | K002138 | 000 |
| 05705244008892 | K002138 | 000 |
| 05705244009011 | K002138 | 000 |
| 05705244009035 | K002138 | 000 |
| 05705244009141 | K002138 | 000 |
| 05705244009165 | K002138 | 000 |
| 05705244009318 | K002138 | 000 |
| 05705244005211 | K002138 | 000 |