The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Safety Shield Suction Catheter.
| Device ID | K873810 |
| 510k Number | K873810 |
| Device Name: | SAFETY SHIELD SUCTION CATHETER |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | BALLARD MEDICAL PRODUCTS 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | E. M Chamberlain,jr |
| Correspondent | E. M Chamberlain,jr 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 | 1987-09-18 |
| Decision Date | 1987-12-11 |