The following data is part of a premarket notification filed by National Catheter Co. Div. Mallinckrodt with the FDA for Double Lumen Tracheal Tube.
| Device ID | K802505 |
| 510k Number | K802505 |
| Device Name: | DOUBLE LUMEN TRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | NATIONAL CATHETER CO. DIV. MALLINCKRODT 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-15 |
| Decision Date | 1981-03-13 |