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 |