The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Bal Cath.
Device ID | K923487 |
510k Number | K923487 |
Device Name: | BAL CATH |
Classification | Tube, Aspirating, Bronchoscope, Rigid |
Applicant | BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
Contact | Chamberlain, Jr |
Correspondent | Chamberlain, Jr BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
Product Code | KTR |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-15 |
Decision Date | 1993-07-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BAL CATH 76244589 2515307 Live/Registered |
AVENT, INC. 2001-04-23 |
BAL CATH 74351867 1793553 Dead/Cancelled |
Ballard Medical Products 1993-01-25 |