The following data is part of a premarket notification filed by Dideco S.p.a. with the FDA for Ideal: System With Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator.
| Device ID | K030154 |
| 510k Number | K030154 |
| Device Name: | IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Applicant | DIDECO S.P.A. 195 WEST ST. Waltham, MA 02451 -1163 |
| Contact | Barry Sall |
| Correspondent | Barry Sall DIDECO S.P.A. 195 WEST ST. Waltham, MA 02451 -1163 |
| Product Code | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-16 |
| Decision Date | 2003-03-31 |
| Summary: | summary |