The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Neutral Luer Activated Device (one-link Needle-free Iv Connector) And Extension Sets.
| Device ID | K132734 |
| 510k Number | K132734 |
| Device Name: | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. 32650 N WILSON RD. Round Lake, IL 60073 |
| Contact | Gary Chumbimune |
| Correspondent | Gary Chumbimune BAXTER HEALTHCARE CORP. 32650 N WILSON RD. Round Lake, IL 60073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-03 |
| Decision Date | 2013-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412613500 | K132734 | 000 |
| 50085412091797 | K132734 | 000 |
| 50085412091803 | K132734 | 000 |
| 50085412091827 | K132734 | 000 |
| 50085412091834 | K132734 | 000 |
| 50085412475382 | K132734 | 000 |
| 50085412475399 | K132734 | 000 |
| 50085412475405 | K132734 | 000 |
| 50085412475412 | K132734 | 000 |
| 50085412476723 | K132734 | 000 |
| 50085412599606 | K132734 | 000 |
| 50085412599613 | K132734 | 000 |
| 50085412599620 | K132734 | 000 |
| 50085412599750 | K132734 | 000 |
| 50085412613470 | K132734 | 000 |
| 50085412613487 | K132734 | 000 |
| 50085412613494 | K132734 | 000 |
| 50085412091780 | K132734 | 000 |