The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Ld-six Arterial Blood Filter For Extra. Service.
| Device ID | K902518 |
| 510k Number | K902518 |
| Device Name: | LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Contact | A Dickstein |
| Correspondent | A Dickstein PALL BIOMEDICAL PRODUCTS CO. 77 CRESCENT BEACH RD. Glen Cove, NY 11542 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-06 |
| Decision Date | 1990-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35034480306105 | K902518 | 000 |
| 35034480004056 | K902518 | 000 |
| 35034480000409 | K902518 | 000 |
| 35034480000393 | K902518 | 000 |