The following data is part of a premarket notification filed by Welmed Systems, Inc. with the FDA for Suction Catheter Kit.
| Device ID | K863497 |
| 510k Number | K863497 |
| Device Name: | SUCTION CATHETER KIT |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | WELMED SYSTEMS, INC. P.O. BOX 599 West Swanzey, NH 03469 |
| Contact | David B Peters |
| Correspondent | David B Peters WELMED SYSTEMS, INC. P.O. BOX 599 West Swanzey, NH 03469 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-10-06 |