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 |