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510(k) K863593

Device
SARNS SAFETY LOOP
Applicant
3M HEALTH CARE, SARNS
510(k) number
K863593
Product code
DWD  
Decision
Substantially Equivalent (SESE)
Decision date
1986-11-18
Date received
1986-09-15
Regulation
870.4430
Classification name
Suction Control, Intracardiac, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH W O'DONNELL
Address
6200 Jackson Rd. P.O. Box 1247 Ann Arbor MI US 48106 48106

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DWD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K992657IBC VRV, MODEL 1350International Biophysics Corp.2000-02-18
K920077NIKKISO NK PUMPInternational Medical Products, Inc.1993-09-29
K915480B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.Bd Becton Dickinson Vacutainer Systems Preanalytic1992-01-07
K915481B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINTBd Becton Dickinson Vacutainer Systems Preanalytic1992-01-07
K915482B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PTBd Becton Dickinson Vacutainer Systems Preanalytic1992-01-07
K905311DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.Baxter Bentley Laboratories, Inc.1991-01-15
K895427MEDISEAL SUCTION CANISTERDeroyal Industries, Inc.1990-01-19
K864503MODIFIED RLV-2100 BAmerican Omni Medical, Inc.1987-01-06
K862540LEFT VENTRICULAR VENT VALVE MODEL NO. GLVGish Biomedical, Inc.1986-08-29
K861428SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100American Omni Medical, Inc.1986-06-26
K851406AJDJUSTABLE SUCTION CONTROL VALVEAmerican Omni Medical, Inc.1985-08-05
K830149IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO-Instrumentation Laboratory CO1983-02-28
K830150VEINPREP VEIN GRAFT PREP. KIT A277723Atrium Medical Corp.1983-02-28
K760894VACUUM RELIEF VALVEDelta Medical Industries1976-12-09

Legacy Summary#

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FDA Review#

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