meddevicedb.com FDA Device Reference

Review Panel

Cardiovascular FDA 510(k) Clearances & Devices

Cleared Devices
19,212
Product Codes (page)
43
Latest Decision
2006-01-18

Clearances · page 80 of 193

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K051145 CRITIVIEW Critisense , Ltd. DPW Class II 2006-01-18
K052557 SUPER SHEATH INTRODUCER SHEATH Togo Medikit Co., Ltd. DRE Class II 2006-01-17
K052570 TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 Cardiacassist, Inc. DWF Class II 2006-01-17
K052642 SUTURING WASHER First Call, Inc. MAB Class II 2006-01-17
K053460 MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, Fox Hollow Technologies MCW Class II 2006-01-13
K052976 DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES GE Healthcare DQK Class II 2006-01-13
K052295 CARDIOSOFT PC ECG, USB VERSION Cardiosoft, L.P. DPS Class II 2006-01-13
K052459 6248VAL ADJUSTABLE VALVE Medtronic Vascular DTL Class II 2006-01-11
K052970 SIMPLICI-T ANNULOPLASTY SYSTEM Medtronic Heart Valves KRH Class II 2006-01-11
K053130 ONYX II FINGER PULSE OXIMETER, MODEL 9550 Nonin Medical, Inc. DQA Class II 2006-01-11
K051271 OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR Nellcor Puritan Bennett, Inc. DQA Class II 2006-01-10
K053522 PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00 Philips Medizin Systeme Boeblingen GmbH MHX Class II 2006-01-10
K052556 CG-7000DX-BT ECG RECORDER/TRANSMITTER Card Guard Scientific Survival , Ltd. DXH Class II 2006-01-09
K052964 EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN Boston Scientific Corp DSY Class II 2006-01-06
K052619 THE FINGER GUARD T F & G Products DQA Class II 2006-01-06
K053437 EKOS MICRO-INFUSION SYSTEM Ekos Corp. NUI Class II 2006-01-06
K053209 TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM Suntech Medical, Inc. DXN Class II 2006-01-05
K051847 KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR Kodon(Tianjin)Electronic&Electrical Apparatus Co., DXN Class II 2006-01-05
K051880 RIO ASPIRATION CATHETER Boston Scientific Corp QEZ Class II 2006-01-04
K051990 ECHELON MICRO CATHETER Micro Therapeutics, Inc. KRA Class II 2006-01-04
K052119 TESLAGUARD, MODEL EFT G04 Mammendorfer Institute For Physics & Medicine GmbH MWI Class II 2006-01-03
K052316 POWERHEART ECD Cardiac Science, Inc. MKJ Class III 2006-01-03
K053432 EKOS MICRO-INFUSION SYSTEM Ekos Corp. QEY Class II 2005-12-30
K053303 CARDIOCOM COMMANDER III Cardiocom, LLC DXN Class II 2005-12-30
K053304 COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM Cardiocom, LLC DXN Class II 2005-12-30
K053440 AMPLATZER SIZING BALLOON II Aga Medical Corp. MJN Class II 2005-12-30
K053016 WIRELESS PHYSIOLOGIC MONITORING SYSTEM Edwards Lifesciences, LLC DXO Class II 2005-12-30
K052972 DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 GE Healthcare MSX Class II 2005-12-29
K051903 FETALGARD LITE-NIBP, MODEL FGL-NIBP Analogic Corporation DXN Class II 2005-12-27
K052678 AQ-830 SLIM BODY, BODY FAT MONITOR Limax Electronics Co., Ltd. MNW Class II 2005-12-27
K052283 HEART STG SYSTEM AND SOFTWARE Stethographics, Inc. DQD Class II 2005-12-23
K053395 BP PRO BLOOD PRESSURE MONITOR Card Guard Scientific Survival , Ltd. DXN Class II 2005-12-23
K052669 AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 Nonin Medical, Inc. DQA Class II 2005-12-23
K042404 LIFEPAK, MODEL 1000 Medtronic Emergency Response Systems, Inc. MKJ Class III 2005-12-22
K053369 MEDILOG DARWIN HOLTER ANALYSIS Huntleigh Healthcare DQK Class II 2005-12-22
K052865 HOSPIRA CATH LAB CONVENIENCE KITS Icu Medical, Inc. DQO Class II 2005-12-22
K051257 ADULT CEREBRAL OXIMETER, MODEL 2040 Cas Medical Systems, Inc. DQA Class II 2005-12-22
K053269 MASIMO SET RAD-8 PULSE OXIMETER Masimo Corporation DQA Class II 2005-12-21
K052288 VITALOGIK Mennen Medical , Ltd. DSI Class II 2005-12-20
K053116 STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX Boston Scientific Corp DQY Class II 2005-12-16
K052727 ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 Rossmax International , Ltd. DXN Class II 2005-12-16
K052160 ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) Welch Allyn, Inc. DSI Class II 2005-12-16
K052744 C2000 AUTOMATED MANIFOLD KIT Acist Medical Systems, Inc. DXT Class II 2005-12-16
K052646 BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 Biospace Corporation Limited MNW Class II 2005-12-16
K051896 MODEL 750E SERIES MONITOR Cas Medical Systems, Inc. MWI Class II 2005-12-16
K052081 REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA Estech, Inc. DWF Class II 2005-12-16
K053118 STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX Boston Scientific Corp DQY Class II 2005-12-16
K052303 READMYHEART, MODEL RMH2.0 Dailycare Biomedical, Inc. DPS Class II 2005-12-16
K053011 PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 Bio Protech, Inc. DRX Class II 2005-12-14
K052522 STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2 Stayhealthy, Inc. MNW Class II 2005-12-13
K052258 VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER Vascular Solutions, Inc. DQY Class II 2005-12-13
K051373 CRONUS GUIDEWIRE, MODEL 001-001470-1 Stereotaxis, Inc. NDQ Class II 2005-12-09
K052428 RESOLUTION ENDOVASCULAR SYSTEM Omnisonics Medical Technologies QEY Class II 2005-12-08
K052841 MIRA-FLEX 18 MICROCATHETER Cook, Inc. KRA Class II 2005-12-08
K051513 BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER Bipore, Inc. DYB Class II 2005-12-07
K052738 INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 Veinrx, Inc. KRA Class II 2005-12-06
K052644 SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER St Jude Medical DYB Class II 2005-12-05
K051736 FOX PULSE OXIMETER Shunsuke Nakanishi DQA Class II 2005-12-02
K053083 DATRIX CARDIO WIFI ELECTROCARDIOGRAPH Datrix DPS Class II 2005-11-30
K052339 ASAHI PTCA GUIDE WIRE Asahi Intecc Co., Ltd. DQX Class II 2005-11-30
K052578 BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J Bard Peripheral Vascular, Inc. DTK Class II 2005-11-25
K052872 IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A Taidoc Technology Corporation DXN Class II 2005-11-23
K052834 MREYE EMBOLIZATION COIL Cook, Inc. KRD Class II 2005-11-23
K052257 VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER Vascular Solutions, Inc. DQY Class II 2005-11-23
K052524 BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT Medtronic Perfusion Systems DWF Class II 2005-11-22
K053027 VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) Welch Allyn, Inc. MWI Class II 2005-11-22
K052784 DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900 Welch Allyn, Inc. DXN Class II 2005-11-22
K052977 DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES GE Healthcare DQK Class II 2005-11-22
K052381 GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER Zerusa Limited DTL Class II 2005-11-21
K051149 MEDITECH MODEL ABPM-04 Meditech Kft. DXN Class II 2005-11-18
K052961 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN Philips Medical Systems DRG Class II 2005-11-18
K052899 ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC Genesee Biomedical, Inc. KRH Class II 2005-11-17
K052565 ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF Genesee Biomedical, Inc. KRH Class II 2005-11-17
K052377 PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. Philips Medizin Systeme Boeblingen GmbH DQA Class II 2005-11-17
K052603 REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS Alliance Medical Corp. NLH Class II 2005-11-16
K051658 INFINITY ALPHA Draeger Medical Systems, Inc. MHX Class II 2005-11-16
K052414 REPROCESSED ELECTROPHYSIOLOGY CATHETER Alliance Medical Corp. NLH Class II 2005-11-16
K052186 NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P Nellcor Puritan Bennett, Inc. DQA Class II 2005-11-10
K051450 EXTENDED MEASUREMENTS SYSTEM Inovise Medical, Inc. DQD Class II 2005-11-10
K053025 JOSTRA HLM TUBING SET Maquet Cardiopulmonary, AG DWE Class II 2005-11-10
K052829 WRISTOX MODEL 3100 PULSE OXIMETER Nonin Medical, Inc. DQA Class II 2005-11-10
K052256 ANGIOJET XPEEDIOR 120 CATHETER Possis Medical, Inc. QEZ Class II 2005-11-10
K052860 CG FUTURE ANNULOPLASTY BAND Medtronic Heart Valves KRH Class II 2005-11-10
K052280 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM Boston Scientific Corp NFA Class II 2005-11-07
K052791 MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER Invatec Innovative Technologies, S.R.L. DQY Class II 2005-11-04
K051274 INVOS SYSTEM Somanetics Corp. MUD Class II 2005-11-04
K051312 SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS Veryan Medical Limited DSY Class II 2005-11-04
K051799 DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS Coeur, Inc. DXT Class II 2005-11-02
K051561 ASAHI ANGIOGRAPHIC CATHETER Asahi Intecc Co., Ltd. DQO Class II 2005-11-02
K052801 INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 Philips Medizin Systeme Boeblingen GmbH MHX Class II 2005-11-02
K052883 CARDIOSERVER Datrix DQK Class II 2005-11-01
K052756 DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM GE Healthcare MHX Class II 2005-11-01
K051589 SLIMMANAGER, MODEL SM-X, SM-E Aiia Communication, Inc. MNW Class II 2005-10-31
K051580 VP SHEATH Flowcardia, Inc. DQY Class II 2005-10-31
K052757 PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER Biotronik AG LIT Class II 2005-10-28
DEN050006 CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM Cardiomems, Inc. NQH Class II 2005-10-28
K050233 OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI Omron Healthcare, Inc. DXN Class II 2005-10-28
K051248 VYGON MICRO-ACCESS SAFETY INTRODUCER KIT Vygon Corp. DYB Class II 2005-10-27
K052783 MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX Boston Scientific Corp DQX Class II 2005-10-27
K052416 PERIPRO PATCH Hancock/Jaffe Laboratories DXZ Class II 2005-10-25

19,212 clearances in the Cardiovascular panel. Data: openFDA.