The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Baxter Laparoscopic Cholangiography Catheters.
| Device ID | K905707 |
| 510k Number | K905707 |
| Device Name: | BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Ronald H Bergeson |
| Correspondent | Ronald H Bergeson BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-21 |
| Decision Date | 1991-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103043693 | K905707 | 000 |