Cleared Traditional

PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE

K980762 · Pall Corp. · Cardiovascular

Sep 1998

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K980762 is an FDA 510(k) clearance for the PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE, a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II — Special Controls, product code DTM), submitted by Pall Corp. (East Hills, US). The FDA issued a Cleared decision on September 1, 1998, 186 days after receiving the submission on February 27, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4260.

Submission Details

510(k) Number	K980762 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 1998
Decision Date	September 01, 1998
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement