Cleared Traditional

S3 MAST PUMP

K972321 · Stoeckert Instrumente · Cardiovascular
Feb 1998
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K972321 is an FDA 510(k) clearance for the S3 MAST PUMP, a Pump, Blood, Cardiopulmonary Bypass, Roller Type (Class II — Special Controls, product code DWB), submitted by Stoeckert Instrumente (North Attleboro, US). The FDA issued a Cleared decision on February 27, 1998, 249 days after receiving the submission on June 23, 1997. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4370.

Submission Details

510(k) Number K972321 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1997
Decision Date February 27, 1998
Days to Decision 249 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWB — Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4370

Similar Devices — DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

All 20
Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1
K162843 · Terumo Cardiovascular Systems Corporation · Nov 2016
LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
K131618 · Terumo Cardiovascular Systems Corporation · Sep 2013
ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
K112587 · Terumo Cardiovascular Systems Corp. · Dec 2011
CSS-CARDIOPLEGIA SAFETY SYSTEM
K973237 · Medtronic Bio-Medicus, Inc. · Apr 1998
S3 CYCLIC RPM CONTROL
K971520 · Stoeckert Instrumente · Sep 1997
COBE CENTURY PERFUSION PUMP
K960974 · Cobe Cardiovascular, Inc. · Jul 1997