SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS— 510(k) K810079

Name: FDA 510(k) clearance K810079
Creator: U.S. Food and Drug Administration
Published: 1981-01-30

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K810079 for SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS, Substantially Equivalent on 1981-01-30. Applicant: 3M Health Care, Sarns. Device class: 1.

Clearance details

Applicant: 3M Health Care, Sarns
Product code: Code KRI
Device class: Class 1
Regulation: 21 CFR 870.4200
Advisory panel: Cardiovascular
Date received: 1981-01-13
Decision date: 1981-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRI

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K020365 — 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE2002-05-03
K992635 — INTERFACE MODULE IDDD1999-12-20
K990512 — STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS1999-11-23
K934782 — AMMEX TUBING ORGANIZER1993-11-18
K926233 — CARDIO2 CYCLE1993-06-04

More clearances from 3M Health Care, Sarns

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K960916 — SAMS 8000 CARDIOPLEGIA MONITOR1996-06-04
K953901 — SARNS 800 ROLLER PUMP1996-04-19
K950739 — 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM1995-11-17
K941653 — SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION1994-08-24
K941654 — SARNS FILTERED VENOUS RESERVIOR MODIFICATION1994-07-26

Recalls naming K810079

K-number listed on FDA's recall record

Z-0157-2015 — Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activityClass II·Terminated·Terumo Cardiovascular Systems Corp·20110301

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K810079.

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