AVECOR PRE-BYPASS FILTER— 510(k) K940126

Name: FDA 510(k) clearance K940126
Creator: U.S. Food and Drug Administration
Published: 1994-06-28

Substantially Equivalent

Avecor Cardiovascular, Inc.

FDA 510(k) clearance K940126 for AVECOR PRE-BYPASS FILTER, Substantially Equivalent on 1994-06-28. Applicant: Avecor Cardiovascular, Inc.. Device class: 2.

Clearance details

Applicant: Avecor Cardiovascular, Inc.
Product code: Code KRJ
Device class: Class 2
Regulation: 21 CFR 870.4280
Advisory panel: Cardiovascular
Date received: 1994-01-10
Decision date: 1994-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRJ

view all

K990276 — POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER1999-10-01
K982385 — POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER1999-02-01
K900672 — PREBYPASS FILTER, CAT. NO. FPB-51990-04-03
K885154 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM1989-02-22
K884390 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER1988-12-21

More clearances from Avecor Cardiovascular, Inc.

view all

K973760 — AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE1998-02-18
K964017 — AFFINITY BLOOD PUMP SYSTEM1997-08-05
K971105 — MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM1997-07-11
K952532 — AFFINITY ARTERIAL BLOOD FILTER1995-10-06
K936003 — AFFINITY CVR1994-06-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.