The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Continuflo Solution Set/secondary Medication Set.
| Device ID | K961225 |
| 510k Number | K961225 |
| Device Name: | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | Mary Ellen Snyder |
| Correspondent | Mary Ellen Snyder BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-29 |
| Decision Date | 1996-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412486517 | K961225 | 000 |
| 50085412048456 | K961225 | 000 |
| 50085412031854 | K961225 | 000 |
| 50085412031793 | K961225 | 000 |
| 50085412021152 | K961225 | 000 |
| 50085412020599 | K961225 | 000 |
| 50085412014314 | K961225 | 000 |
| 50085412003943 | K961225 | 000 |
| 50085412002335 | K961225 | 000 |
| 50085412002144 | K961225 | 000 |
| 50085412002137 | K961225 | 000 |
| 50085412653636 | K961225 | 000 |
| 20809160146610 | K961225 | 000 |
| 20809160303723 | K961225 | 000 |
| 50085412048470 | K961225 | 000 |
| 50085412048548 | K961225 | 000 |
| 50085412080920 | K961225 | 000 |
| 50085412080906 | K961225 | 000 |
| 50085412077449 | K961225 | 000 |
| 50085412074424 | K961225 | 000 |
| 50085412071119 | K961225 | 000 |
| 50085412071102 | K961225 | 000 |
| 50085412068386 | K961225 | 000 |
| 50085412051708 | K961225 | 000 |
| 50085412049101 | K961225 | 000 |
| 50085412049064 | K961225 | 000 |
| 50085412048999 | K961225 | 000 |
| 50085412048982 | K961225 | 000 |
| 50085412048975 | K961225 | 000 |
| 10884389466797 | K961225 | 000 |