Company ยท US
Pall Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2021. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2021 | K211286 | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger Pall Corporation | CAH |
| Mar 7, 2003 | K022167 | PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM Pall Corp. | CAC |
| Dec 16, 1999 | K993379 | PALL SUPOR AEF FILTER Pall Corp. | FPB |
| Sep 1, 1998 | K980762 | PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE Pall Corp. | DTM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2014 | Pall Corporation PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter.
The filters are individually packaged in a clear, plastic pouch Terminated |
CAH | K791307 |
| Jul 21, 2011 | Pall Corporation PALL Medical LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE. CATALOG/MODEL/Reorder Number: LGB. CLASSIFICATION NAME: Filter, Blood, Cardiopulmonary Bypass Arterial L Terminated |
LGB | K902518 |