The following data is part of a premarket notification filed by Kendall Healthcare Products Co. Div.of Tyco Health with the FDA for Curity(r) Percutaneous Catheters.
| Device ID | K895972 |
| 510k Number | K895972 |
| Device Name: | CURITY(R) PERCUTANEOUS CATHETERS |
| Classification | Catheter, Percutaneous |
| Applicant | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Contact | Jeffrey L Dow |
| Correspondent | Jeffrey L Dow KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH 15 HAMPSHIRE ST. Mansfield, MA 02048 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-12 |
| Decision Date | 1990-03-13 |