The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Heimlich Micro Trach.
| Device ID | K895130 | 
| 510k Number | K895130 | 
| Device Name: | HEIMLICH MICRO TRACH | 
| Classification | Tube, Tracheostomy (w/wo Connector) | 
| Applicant | BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 | 
| Contact | E.martin Chamberlain | 
| Correspondent | E.martin Chamberlain BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 | 
| Product Code | BTO | 
| CFR Regulation Number | 868.5800 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1989-08-17 | 
| Decision Date | 1989-11-07 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  HEIMLICH MICRO TRACH  77641368  not registered Dead/Abandoned | TyTek Industries Inc. 2008-12-30 | 
|  HEIMLICH MICRO TRACH  74095919  1700389 Dead/Cancelled | INNOVATIVE MEDICAL DEVELOPMENT CORP. 1990-09-11 |