The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Lillipup Pmp, Lilliput Pmp Integrated.
| Device ID | K151713 |
| 510k Number | K151713 |
| Device Name: | LILLIPUP PMP, LILLIPUT PMP INTEGRATED |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | SORIN GROUP ITALIA S.R.L. 86, VIA STATALE 12 NORD Mirandola, IT 41037 |
| Contact | Luigi Vecchi |
| Correspondent | Barry S. Sall PAREXEL CONSULTING LLC 195 WEST STREET Waltham, MA 02451 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-25 |
| Decision Date | 2015-11-06 |
| Summary: | summary |