510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980762Substantially Equivalent

Pall Stat-Prime D Blood Filter for Extracorporeal Service

Pall Corp., East Hills NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980762 is the FDA 510(k) clearance record for PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE, a class II device, cleared for Pall Corp. on under FDA product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line). FDA records list 3 510(k) clearances for Pall Corp., from to . As of , FDA records show no recalls naming K980762.

Clearance record

Decision date
Received
(186 days to decision)
Product code
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Regulation
21 CFR 870.4260
Device class
Class II
Review panel
Cardiovascular
Applicant
Pall Corp. 2200 Northern Blvd., East Hills NY
510(k) summary
Statement
Third party review
No

Clearances, product code DTM

Trailing 12 months
1 clearance under product code DTM in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DTM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260