The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Trach Care Catheter.
| Device ID | K872621 |
| 510k Number | K872621 |
| Device Name: | TRACH CARE CATHETER |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | Ernest Chamberlain |
| Correspondent | Ernest Chamberlain BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-06 |
| Decision Date | 1987-09-15 |