The following data is part of a premarket notification filed by Aga Medical Products, Inc. with the FDA for Combination Trach Tie & Ventilator Antidisconnect.
| Device ID | K925438 |
| 510k Number | K925438 |
| Device Name: | COMBINATION TRACH TIE & VENTILATOR ANTIDISCONNECT |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | AGA MEDICAL PRODUCTS, INC. 903 DOLPHIN DR. Malvern, PA 19355 |
| Contact | Michael Schuster |
| Correspondent | Michael Schuster AGA MEDICAL PRODUCTS, INC. 903 DOLPHIN DR. Malvern, PA 19355 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-28 |
| Decision Date | 1993-02-17 |