The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Intravia Container, Empty.
| Device ID | K964853 |
| 510k Number | K964853 |
| Device Name: | INTRAVIA CONTAINER, EMPTY |
| Classification | Container, I.v. |
| Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | Mary E Snyder |
| Correspondent | Mary E Snyder BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-03 |
| Decision Date | 1997-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20085412035264 | K964853 | 000 |
| 20085412029577 | K964853 | 000 |
| 20085412029560 | K964853 | 000 |
| 50085412003509 | K964853 | 000 |
| 50085412003462 | K964853 | 000 |
| 20085412003195 | K964853 | 000 |
| 20085412000040 | K964853 | 000 |