INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM— 510(k) K885154

Name: FDA 510(k) clearance K885154
Creator: U.S. Food and Drug Administration
Published: 1989-02-22

Substantially Equivalent

Medtronic Blood Systems, Inc.

FDA 510(k) clearance K885154 for INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM, Substantially Equivalent on 1989-02-22. Applicant: Medtronic Blood Systems, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Blood Systems, Inc.
Product code: Code KRJ
Device class: Class 2
Regulation: 21 CFR 870.4280
Advisory panel: Cardiovascular
Date received: 1988-12-15
Decision date: 1989-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, 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
K940126 — AVECOR PRE-BYPASS FILTER1994-06-28
K900672 — PREBYPASS FILTER, CAT. NO. FPB-51990-04-03
K884390 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER1988-12-21

More clearances from Medtronic Blood Systems, Inc.

view all

K944957 — TEMPORARY MYOCARDIAL PACING LEAD, MODEL 65001995-07-14
K944966 — UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 64921995-07-14
K893207 — CLOSED CHEST SUPPORT CIRCUIT1989-12-12
K893678 — DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H1989-11-27
K891687 — EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE1989-05-31

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