Atlas FDA

HLM TUBING SET WITH BIOLINE COATING

FDA 510(k) clearance K080592 · decided 2008-09-11

Clearance details

K-number
K080592
Device name
HLM TUBING SET WITH BIOLINE COATING
Applicant
Maquet Cardiopulmonary, AG
Decision
Substantially Equivalent
Date received
2008-03-03
Decision date
2008-09-11
Days to decision
192 days
Clearance type
Special
Product code
DWE
Device class
2
Regulation number
870.4390
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Hirrlingen, DE
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087 recall (Z-1498-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962 recall (Z-1499-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-T 8803#Circ Circuit Small Patient Material: 701048539 recall (Z-1500-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 5103#CPS Tubing Pack Material: 701048690 recall (Z-1501-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 17207 3/8 ECC PACK Material: 701049346 recall (Z-1502-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-T-22800 Material: 701049506 recall (Z-1503-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 3700 Tubing Pack Material: 701049510 recall (Z-1504-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-T 9403 Small Patient Tubing Pack Material: 701049994 recall (Z-1505-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 21502# Med City Childr Material: 701050060 recall (Z-1506-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228 recall (Z-1507-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 24500 ADULT ECC Material: 701050253 recall (Z-1508-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 22701 Material: 701050790 recall (Z-1509-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 4901 Material: 701050839 recall (Z-1510-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859 recall (Z-1511-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BO-TOP 20700 SMALL PATIENT 3/8 Material: 701050966 recall (Z-1512-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BO-TOP 26300 CUSTOM PACK Material: 701050975 recall (Z-1513-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 15705 Material: 701051122 recall (Z-1514-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179 recall (Z-1515-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 7005 UAMC Pediatric ECC Pack Material: 701051515 recall (Z-1516-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 5502 ECC Pack Material: 701051791 recall (Z-1517-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 1601#QUADROX iD - Pack Material:701052285 recall (Z-1518-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287 recall (Z-1519-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BO-T 6600 TUBING PACK Material:701052324 recall (Z-1520-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 25500 ECC 3/8 w/QiD Material: 701052461 recall (Z-1521-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BO-TOP 30300 Material:701052623 recall (Z-1522-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 31000 PEDIATRIC ECC Material:701052843 recall (Z-1523-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 32200 ECC PACK - Material: 701053319 recall (Z-1524-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-T 8805 ECC PACK Material: 701053361 recall (Z-1525-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486 recall (Z-1526-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752 recall (Z-1527-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 33501 1/4" ECC PACK Material: 701053754 recall (Z-1528-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 33700 ECC 3/8" PACK Material: 701053845 recall (Z-1529-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 25001 MONTEFIORE Material: 701053906 recall (Z-1530-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150 recall (Z-1531-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 24202 ADULT ECC Material:701054295 recall (Z-1532-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC Material:701054438 recall (Z-1533-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 21503 ECC 1/4" AV LOOP Material:701054776 recall (Z-1534-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BO-TOP 13901 RAPID RESPONSE Material:701054874 recall (Z-1535-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-T 22706 SAMPLE MANIFOLD Material:701054912 recall (Z-1536-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-T 8025 1/4" ECC Pack with RF32 Material:701055142 recall (Z-1537-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BO-TOP 30901 CUSTOM CPB PACK Material: 701055372 recall (Z-1538-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 37200 CIRCULATORY CIRC Material: 701055388 recall (Z-1539-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 37500 ECC QUADROX ID Material: 701055601 recall (Z-1540-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 38002 ADULT SPECIALTY Material: recall (Z-1541-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 38300 ADULT CPS QID Material: 701055862 recall (Z-1542-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID Material: 701055866 recall (Z-1543-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993 recall (Z-1544-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-T 8029 PRESSURE PIGTAIL 6" Material: 701055995 recall (Z-1545-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-T 4906 PEDIARIC CPB PACK Material: 701056041 recall (Z-1546-2019)Maquet Cardiovascular, LLC2019-05-31
Maquet Getinge-BEQ-TOP 38900 ECC PACK Material: 701056368 recall (Z-1547-2019)Maquet Cardiovascular, LLC2019-05-31