The following data is part of a premarket notification filed by Interventional Medical, Inc. with the FDA for Large Lumen Y Adapter W/rotating Device.
| Device ID | K880831 |
| 510k Number | K880831 |
| Device Name: | LARGE LUMEN Y ADAPTER W/ROTATING DEVICE |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | INTERVENTIONAL MEDICAL, INC. P.O. BOX 2186 35A CHERRY HILL DRIVE Danvers, MA 01923 |
| Contact | Denis T Kokernak |
| Correspondent | Denis T Kokernak INTERVENTIONAL MEDICAL, INC. P.O. BOX 2186 35A CHERRY HILL DRIVE Danvers, MA 01923 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-01 |
| Decision Date | 1988-05-10 |