The following data is part of a premarket notification filed by Medi-craft Ltd. with the FDA for Suction Catheter Kit.
| Device ID | K861949 |
| 510k Number | K861949 |
| Device Name: | SUCTION CATHETER KIT |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | MEDI-CRAFT LTD. 7526 BATH RD MISSISSAUGA Ontario L4t 1l2, CA |
| Contact | T. A Donat |
| Correspondent | T. A Donat MEDI-CRAFT LTD. 7526 BATH RD MISSISSAUGA Ontario L4t 1l2, CA |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-10-22 |