Home / Device Classification / KRL

KRL — Detector, Bubble, Cardiopulmonary Bypass Class II

FDA Device Classification

Classification Details

Product Code
KRL
Device Class
Class II
Regulation Number
870.4205
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K103469sorin group deutschlandSTOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05January 18, 2011
K090698terumo cardiovascular systemsCAPIOX BUBBLE TRAP WITH X-COATINGJune 8, 2009
K071231luna innovationsEDAC QUANTIFIERMay 17, 2007
K961364rocky mountain researchAUTOMATIC TUBING CLAMP SYSTEM (ATC)October 31, 1996
K961598rocky mountain researchELS AUTOMATIC TUBING CLAMP SYSTEMOctober 29, 1996
K9406513m health care, sarnsSARNS ULTRASONIC AIR SENSORMay 24, 1994
K9359773m health care, sarnsSARNS AIR DETECTION SYSTEMFebruary 4, 1994
K925661sorin biomedica, fiat, usaSTOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULEMay 18, 1993
K925541sorin biomedica, fiat, usaSTOCKERT 1/4 BUBBLE SENSORFebruary 2, 1993
K911632terumo medicalCAPIOX(R) BUBBLE TRAPJuly 9, 1991
K864619shileyCAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITORFebruary 3, 1987
K861860cobe laboratoriesCOBE ACCESSORY INTERFACE MODULE (AIM)July 18, 1986
K842054cobe laboratoriesCOBE AEPSAugust 2, 1984
K803102delta medical industriesARTERIAL BUBBLE TRAP K-20December 22, 1980