The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Kendall Infant Ecmo Venovenous Catheter-dual Lumen.
| Device ID | K895352 |
| 510k Number | K895352 |
| Device Name: | KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Jane Arnold |
| Correspondent | Jane Arnold KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-01 |
| Decision Date | 1989-11-29 |