The following data is part of a premarket notification filed by Intec Medical, Inc. with the FDA for Tri Adapter W/adjustable Hemostasis Valves.
| Device ID | K901247 |
| 510k Number | K901247 |
| Device Name: | TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES |
| Classification | Catheter, Flow Directed |
| Applicant | INTEC MEDICAL, INC. P.O. BOX 2186 35A CHERRY HILL DRIVE Danvers, MA 01923 |
| Contact | Kenneth A Spector |
| Correspondent | Kenneth A Spector INTEC MEDICAL, INC. P.O. BOX 2186 35A CHERRY HILL DRIVE Danvers, MA 01923 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-15 |
| Decision Date | 1990-07-31 |