The following data is part of a premarket notification filed by Electro-catheter Corp. with the FDA for Elecath Infant Arterial & Venous Cannu.
| Device ID | K842369 |
| 510k Number | K842369 |
| Device Name: | ELECATH INFANT ARTERIAL & VENOUS CANNU |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | ELECTRO-CATHETER CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-15 |
| Decision Date | 1984-08-27 |