Atlas FDA

SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL

FDA 510(k) clearance K900815 · decided 1990-05-09

Clearance details

K-number
K900815
Device name
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL
Applicant
3M Company
Decision
Substantially Equivalent
Date received
1990-02-21
Decision date
1990-05-09
Days to decision
77 days
Clearance type
Traditional
Product code
DTW
Device class
2
Regulation number
870.4340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Ann Arbor, MI, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR (K910599)Jtl Medical Corp.1993-05-20
STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (K924354)Sorin Biomedica, Fiat, USA, Inc.1993-02-18
CAPIOX LEVEL ALARM (K915337)Terumo Medical Corp.1992-02-21
COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) (K900910)Cobe Laboratories, Inc.1990-05-22
MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE (K873206)Respiratory Support Products, Inc.1987-09-30
GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 (K860076)Gambro, Inc.1986-05-30
SENSOR TAPE CAT. NO. ST-45 (K852407)American Omni Medical, Inc.1985-10-21
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Recalls involving this device

RecordFirmDate
Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400. recall (Z-0655-2007)Terumo Cardiovascular Systems Corp2007-03-27
Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401. recall (Z-0656-2007)Terumo Cardiovascular Systems Corp2007-03-27
Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405. recall (Z-0657-2007)Terumo Cardiovascular Systems Corp2007-03-27
Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406. recall (Z-0658-2007)Terumo Cardiovascular Systems Corp2007-03-27
Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410. recall (Z-0659-2007)Terumo Cardiovascular Systems Corp2007-03-27
Terumo Perfusion System 9000, 100v, with color screen; Model 9000; Catalog No. 164280. recall (Z-0233-2007)Terumo Cardiovascular Systems Corp2006-12-07
Terumo Perfusion System 9000, 220/240v, with color screen; Model 9000; Catalog No. 164290. recall (Z-0234-2007)Terumo Cardiovascular Systems Corp2006-12-07
Terumo Perfusion System 9000, 115v, with color screen; Model 9000; Catalog No. 164300. recall (Z-0235-2007)Terumo Cardiovascular Systems Corp2006-12-07

PMA approvals by this applicant

RecordFirmDate
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011)3M Company1994-11-28
CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010)3M Company1994-05-19
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006)3M Company1992-12-31
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009)3M Company1992-03-13
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008)3M Company1992-01-28
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007)3M Company1990-10-17
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005)3M Company1990-03-08
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004)3M Company1989-11-22