The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Europhilic Slippery Coated Foley Catheter.
| Device ID | K944007 |
| 510k Number | K944007 |
| Device Name: | EUROPHILIC SLIPPERY COATED FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | BAXTER HEALTHCARE CORP. 27636 AVE SCOTT SUITE B Velencia, CA 91355 |
| Contact | Kam H Leung |
| Correspondent | Kam H Leung BAXTER HEALTHCARE CORP. 27636 AVE SCOTT SUITE B Velencia, CA 91355 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1995-06-29 |