The following data is part of a premarket notification filed by Marquette Medical, Inc. with the FDA for Marquette Huber Trap Safety Infusion Set.
| Device ID | K021471 |
| 510k Number | K021471 |
| Device Name: | MARQUETTE HUBER TRAP SAFETY INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MARQUETTE MEDICAL, INC. P.O. BOX 4341 Crofton, MD 20850 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith MARQUETTE MEDICAL, INC. P.O. BOX 4341 Crofton, MD 20850 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-08 |
| Decision Date | 2003-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10812608021281 | K021471 | 000 |
| 10812608021113 | K021471 | 000 |
| 10812608021106 | K021471 | 000 |
| 10812608021090 | K021471 | 000 |
| 10812608021083 | K021471 | 000 |
| 10812608021076 | K021471 | 000 |
| 10812608020109 | K021471 | 000 |
| 10812608020055 | K021471 | 000 |
| 10812608020048 | K021471 | 000 |
| 10812608021359 | K021471 | 000 |
| 10812608021120 | K021471 | 000 |
| 00812608021130 | K021471 | 000 |
| 10812608021274 | K021471 | 000 |
| 10812608021267 | K021471 | 000 |
| 10812608021250 | K021471 | 000 |
| 10812608021243 | K021471 | 000 |
| 10812608021236 | K021471 | 000 |
| 10812608021229 | K021471 | 000 |
| 10812608021168 | K021471 | 000 |
| 10812608021151 | K021471 | 000 |
| 10812608021144 | K021471 | 000 |
| 00812608021369 | K021471 | 000 |