Medical Device Manufacturer · SE , Uppsala

Radi Medical Systems AB - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 1990
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Radi Medical Systems AB Cardiovascular
21 devices
1-21 of 21
Cleared Mar 28, 2013
QUANTIEN MEASUREMENT SYSTEM
K123984 · DQK
Cardiovascular · 92d
Cleared Oct 09, 2009
RADIANALYZER XPRESS
K092105 · DQK
Cardiovascular · 87d
Cleared Jul 01, 2008
PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
K080813 · DXO
Cardiovascular · 102d
Cleared Feb 26, 2008
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
K080206 · DXC
Cardiovascular · 29d
Cleared Dec 04, 2006
PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
K062769 · DXO
Cardiovascular · 80d
Cleared Jan 19, 2005
MODIFICATION TO: RADIANALYZER, MODEL 12711
K042628 · DQK
Cardiovascular · 114d
Cleared Jun 06, 2003
PRESSURE WIRE SENSOR, MODELS 12004/12304
K031662 · DXO
Cardiovascular · 9d
Cleared Dec 24, 2002
FEMOSTOP FEMORAL COMPRESSION SYSTEM
K024107 · DXC
Cardiovascular · 11d
Cleared Oct 03, 2002
RADIANALYZER, MODEL 12710
K022188 · DQK
Cardiovascular · 90d
Cleared Sep 24, 2002
PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
K022187 · DXO
Cardiovascular · 81d
Cleared Dec 18, 2001
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
K013943 · DSK
Cardiovascular · 19d
Cleared Jan 11, 2001
RADIANALYZER, MODEL 12710
K002067 · DSK
Cardiovascular · 188d
Cleared Oct 04, 2000
PRESSURE WIRE SENSOR, MODEL 12003/12303
K002962 · DQX
Cardiovascular · 12d
Cleared Feb 23, 1999
FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER
K983471 · DXC
Cardiovascular · 144d
Cleared Feb 03, 1999
PRESSUREWIRE SENSOR, MODEL #12001
K983506 · DQX
Cardiovascular · 119d
Cleared Sep 18, 1998
FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION...
K982182 · DXC
Cardiovascular · 88d
Cleared Apr 24, 1998
PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR...
K972793 · DQX
Cardiovascular · 270d
Cleared Apr 21, 1998
FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP,...
K980898 · DXC
Cardiovascular · 43d
Cleared Oct 27, 1995
FEMOSTOP, FEMOSTOP PUMP
K954669 · DXC
Cardiovascular · 17d
Cleared Jul 20, 1995
FEMOSTOP II
K944259 · DXC
Cardiovascular · 322d
Cleared Apr 22, 1992
FEMOSTOP
K915280 · DXC
Cardiovascular · 149d
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