The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Pall Stat Prime(tm) Blood Filter For Extra. Use.
| Device ID | K874405 |
| 510k Number | K874405 |
| Device Name: | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE |
| Classification | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Contact | Samuel Wortham |
| Correspondent | Samuel Wortham PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Product Code | JOD |
| CFR Regulation Number | 870.4270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-28 |
| Decision Date | 1987-12-30 |