Atlas FDA

SARNS 8000 MODULAR PERFUSION SYSTEM

FDA 510(k) clearance K915183 · decided 1992-07-08

Clearance details

K-number
K915183
Device name
SARNS 8000 MODULAR PERFUSION SYSTEM
Applicant
3M Health Care, Sarns
Decision
Substantially Equivalent
Date received
1991-11-18
Decision date
1992-07-08
Days to decision
233 days
Clearance type
Traditional
Product code
DTQ
Device class
2
Regulation number
870.4220
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Ann Arbor, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfus recall (Z-0280-2013)Terumo Cardiovascular Systems Corporation2012-11-13
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfus recall (Z-0281-2013)Terumo Cardiovascular Systems Corporation2012-11-13
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular P recall (Z-0282-2013)Terumo Cardiovascular Systems Corporation2012-11-13
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular P recall (Z-0283-2013)Terumo Cardiovascular Systems Corporation2012-11-13
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfus recall (Z-0284-2013)Terumo Cardiovascular Systems Corporation2012-11-13
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular Perfus recall (Z-0285-2013)Terumo Cardiovascular Systems Corporation2012-11-13
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusi recall (Z-0126-2013)Terumo Cardiovascular Systems Corporation2012-10-24
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusi recall (Z-0127-2013)Terumo Cardiovascular Systems Corporation2012-10-24
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Pe recall (Z-0128-2013)Terumo Cardiovascular Systems Corporation2012-10-24
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Pe recall (Z-0129-2013)Terumo Cardiovascular Systems Corporation2012-10-24
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns Modular Perfusi recall (Z-0130-2013)Terumo Cardiovascular Systems Corporation2012-10-24
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusi recall (Z-0131-2013)Terumo Cardiovascular Systems Corporation2012-10-24
Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is recall (Z-2348-2012)Terumo Cardiovascular Systems Corporation2012-09-11
System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for u recall (Z-2218-2012)Terumo Cardiovascular Systems Corporation2012-08-16
Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion system recall (Z-2044-2012)Terumo Cardiovascular Systems Corporation2012-07-19
Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern recall (Z-2045-2012)Terumo Cardiovascular Systems Corporation2012-07-19
Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion Sys recall (Z-2046-2012)Terumo Cardiovascular Systems Corporation2012-07-19
Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion Sys recall (Z-2047-2012)Terumo Cardiovascular Systems Corporation2012-07-19
Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System recall (Z-2048-2012)Terumo Cardiovascular Systems Corporation2012-07-19
Sarns Modular Perfusion System 8000 base, 5 pump 100V. he Sarns Modular Perfusion System 8 recall (Z-2049-2012)Terumo Cardiovascular Systems Corporation2012-07-19
Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor The 8K Arter recall (Z-1450-2012)Terumo Cardiovascular Systems Corporation2012-04-23
Sarns Modular Perfusion System 8000 Catalog number 16413 Arterial Monitor The 8K Arterial recall (Z-1451-2012)Terumo Cardiovascular Systems Corporation2012-04-23
Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3 Temperature-Pr recall (Z-1452-2012)Terumo Cardiovascular Systems Corporation2012-04-23
Sarns Modular Perfusion System 8000 Catalog number 149112 or 78-8067-4840-2 Temperature-Pr recall (Z-1453-2012)Terumo Cardiovascular Systems Corporation2012-04-23
Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Pe recall (Z-0303-2012)Terumo Cardiovascular Systems Corporation2011-11-29
Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The recall (Z-2613-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit Part number 70667-01 Eisenhower Army Med Center Heart Lung Pa recall (Z-2614-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit Part number 70667 Eisenhower Army Med Center Heart Lung Pack, recall (Z-2615-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit Part number 70367-07 Mission St. Joe's - Asheville X-Coated L recall (Z-2616-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit Part number 72427, Oklahoma Heart Hospital X-Coated System 1 recall (Z-2617-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit, Part number 65418-01, Terumo Latin America Seminsa Pediatric recall (Z-2618-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit, Part number 65672-01, Terumo Latin America Seminsa lactante, recall (Z-2619-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit, Part number 65870, Terumo Latin America Pediatric Pack, Ster recall (Z-2620-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Cardiovascular Procedure Kit, Part number 65871, Terumo Latin America Lactante Pack, Steri recall (Z-2621-2011)Terumo Cardiovascular Systems Corporation2011-06-22
Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 115V, Catalog No recall (Z-0562-2011)Terumo Cardiovascular Systems Corporation2010-12-08
Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No recall (Z-0563-2011)Terumo Cardiovascular Systems Corporation2010-12-08
Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402. recall (Z-1002-2007)Terumo Cardiovascular Systems Corp2007-07-07
Terumo Perfusion System 8000 Roller Pump, 220/240V; Model 8000; Catalog No. 16407. recall (Z-1003-2007)Terumo Cardiovascular Systems Corp2007-07-07
Terumo Perfusion System 9000 Roller Pump; Model 9000; Catalog No. 16395. recall (Z-1004-2007)Terumo Cardiovascular Systems Corp2007-07-07
Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400. recall (Z-0236-2007)Terumo Cardiovascular Systems Corp2006-12-07
Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401. recall (Z-0237-2007)Terumo Cardiovascular Systems Corp2006-12-07
Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405. recall (Z-0238-2007)Terumo Cardiovascular Systems Corp2006-12-07
Terumo Perfusion System 8000 Base, 5 pump, 220240v; Model 8000; Catalog No. 16406. recall (Z-0239-2007)Terumo Cardiovascular Systems Corp2006-12-07
Terumo Perfusion System 8000 Base, 4 pump, 100v, Model 8000; Catalog No. 16409. recall (Z-0240-2007)Terumo Cardiovascular Systems Corp2006-12-07
Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410. recall (Z-0241-2007)Terumo Cardiovascular Systems Corp2006-12-07