Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- DSTClip, Vena-Cava2Product Code
- DSWBag, Polymeric Mesh, Pacemaker1Product Code
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter2Product Code
- DSZPacemaker Battery3Product Code
- DTATester, Pacemaker Electrode Function2Product Code
- DTBPermanent Pacemaker Electrode3Product Code
- DTCAnalyzer, Pacemaker Generator Function2Product Code
- DTDPacemaker Lead Adaptor2Product Code
- DTEPulse-Generator, Pacemaker, External2Product Code
- DTFTools, Pacemaker Service1Product Code
- DTGMagnet, Test, Pacemaker1Product Code
- DTISizer, Heart-Valve, Prosthesis1Product Code
- DTJHolder, Heart-Valve, Prosthesis1Product Code
- DTKFilter, Intravascular, Cardiovascular2Product Code
- DSPSystem, Balloon, Intra-Aortic And Control2Product Code
- DSRStimulator, Carotid Sinus Nerve3Product Code
- DSSClip, Vascular2Product Code
- DXYImplantable Pacemaker Pulse-Generator3Product Code
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2Product Code
- DYEReplacement Heart-Valve3Product Code
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter2Product Code
- KFJMaterials, Repair Or Replacement, Pacemaker3Product Code
- KRDDevice, Vascular, For Promoting Embolization2Product Code
- KREAnalyzer, Pacemaker Generator Function, Indirect2Product Code
- KRFCharger, Pacemaker1Product Code
- KRGProgrammer, Pacemaker3Product Code
- KRHRing, Annuloplasty2Product Code
- K253232Seguin Annuloplasty Ring2Cleared 510(K)
- K251982Edwards MC3 Tricuspid annuloplasty ring (4900)2Cleared 510(K)
- K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)2Cleared 510(K)
- K250859TransForm McCarthy Mitral Annuloplasty Ring (TF)2Cleared 510(K)
- K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)2Cleared 510(K)
- K230679WellsForm Tricuspid Annuloplasty Band (WF)2Cleared 510(K)
- K230318Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring2Cleared 510(K)
- K202253TruForm Sievers Annuloplasty Ring2Cleared 510(K)
- K201449SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring2Cleared 510(K)
- K192762Physio Flex Annuloplasty Ring2Cleared 510(K)
- K190506NeoForm Annuloplasty Ring2Cleared 510(K)
- K181132Tri-Ad 2.0 Adams Tricuspid Band2Cleared 510(K)
- K180411MEMO 4D2Cleared 510(K)
- K161815FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band2Cleared 510(K)
- K142221MEMO 3D ReChord2Cleared 510(K)
- K103520CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING2Cleared 510(K)
- K103812MITRA-LIFT2Cleared 510(K)
- K101212MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R2Cleared 510(K)
- K093903ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC2Cleared 510(K)
- K092876SJM ATTUNE ANNULOPLASTY RING2Cleared 510(K)
- K092310SEGUIN ANNULOPLASTY RING2Cleared 510(K)
- K090428ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY, MODEL 735 AC2Cleared 510(K)
- K083623CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 41002Cleared 510(K)
- K083191DETLOGIX ANNULOPLASTY RING, MODEL: 51002Cleared 510(K)
- K083683ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC2Cleared 510(K)
- K083835ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR2Cleared 510(K)
- K083470CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 52002Cleared 510(K)
- K070488MICARDIA ANNULOPLASTY BAND DR2Cleared 510(K)
- K073324MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R2Cleared 510(K)
- K072655ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR2Cleared 510(K)
- K071327MEMO 3D SEMIRIGID ANNULOPLASTY RING2Cleared 510(K)
- K071281UNIRING - ANNULOPLASTY RING WITH SIZERS2Cleared 510(K)
- K071214ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING2Cleared 510(K)
- K061127CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R2Cleared 510(K)
- K052970SIMPLICI-T ANNULOPLASTY SYSTEM2Cleared 510(K)
- K052899ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC2Cleared 510(K)
- K052565ATS SIMULUS ANNULOPLASTY RING, MODEL 700FF2Cleared 510(K)
- K052860CG FUTURE ANNULOPLASTY BAND2Cleared 510(K)
- K042734SJM RIGID SADDLE RING MODEL RSAR-(SIZE)2Cleared 510(K)
- K033685NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 10002Cleared 510(K)
- K032810DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE2Cleared 510(K)
- K032250GEOFORM ANNULOPLASTY RING, MITRAL MODEL 42002Cleared 510(K)
- K023940SHELHIGH BIORING2Cleared 510(K)
- K023185ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 8002Cleared 510(K)
- K022363SJM TAILOR ANNULOPLASTY BAND, MODEL TAB-(SIZE) (TAILOR BAND)2Cleared 510(K)
- K021051ANNULOFLO SYSTEM, MITRAL MODEL AR7002Cleared 510(K)
- K020864EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 49002Cleared 510(K)
- K014161SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)2Cleared 510(K)
- K014037SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)2Cleared 510(K)
- K011395MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B2Cleared 510(K)
- K000119SJM TAILOR ANNULOPLASTY RING, MODEL TARN2Cleared 510(K)
- K992056ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF8002Cleared 510(K)
- K984435MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M2Cleared 510(K)
- K980487CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM2Cleared 510(K)
- K980534DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H2Cleared 510(K)
- K970375ANNULOFLO SYSTEM2Cleared 510(K)
- K961246SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M2Cleared 510(K)
- K960356POSTERIOR ANNULOPLASTY BAND (MODEL 607)2Cleared 510(K)
- K926138CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING2Cleared 510(K)
- K923367COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 46002Cleared 510(K)
- K905175PTI ANNULOPLASTY RING(STERILE)2Cleared 510(K)
- K914972CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS2Cleared 510(K)
- K914602DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED2Cleared 510(K)
- K912554ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI2Cleared 510(K)
- K902159BIFLEX(TM) ANNULOPLASTY RING2Cleared 510(K)
- K893678DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H2Cleared 510(K)
- K831949PROSTHETIC RINGS #4400 MITRAL & 45002Cleared 510(K)
- K821261PUIG MASSANA-SHILEY ANNULOPLASTY RING2Cleared 510(K)
- K801879PUIG MASSANA-SHILEY ANNULOPLASTY RING2Cleared 510(K)
- K800147FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.2Cleared 510(K)
- K792441CARPENTIER-EDWARDS FLEX. ANNULOPLASTY2Cleared 510(K)
- K792646AMP DIRECT VASCULAR MONITORING SYSTEM2Cleared 510(K)
- K790534MERSILENE SUTURES2Cleared 510(K)
- LDFElectrode, Pacemaker, Temporary2Product Code
- MABMarker, Cardiopulmonary Bypass (Vein Marker)2Product Code
- MALGraft, Vascular, Synthetic/Biologic Composite2Product Code
- MFXVessel Guard Or Cover, To Facilitate Revision Surgeries2Product Code
- MOPRotator, Prosthetic Heart Valve1Product Code
- MZYGraft, Vascular, Stainless Steel Tunneler2Product Code
- NHWElectrode, Pacing And Cardioversion, Temporary, Epicardial2Product Code
- NKOSystem, Balloon, Intra-Aortic And Control, Reprocessed3Product Code
- OKRVentricular Bypass (Assist) Device3Product Code
- OMHPericardial Patch To Facilitate Revision Surgeries2Product Code
- OMRVessel Guard Or Cover2Product Code
- OTDEndovascular Suturing System2Product Code
- OVJPulse Generator, External Pacemaker, Dual Chamber2Product Code
- PALPulmonic Replacement Heart ValveFProduct Code
- PCKPediatric Ventricular Assist DeviceFProduct Code
- PNJLeadless Pacemaker3Product Code
- PNSShort-Term Intravascular Filter Catheter2Product Code
- PSQIntracardiac Patch Or Pledget, Biologically Derived2Product Code
- PSTAortic Annuloplasty Ring2Product Code
- QABPacing System Analyzer2Product Code
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band
- Page Type
- Cleared 510(K)
- 510(k) Number
- K161815
- 510(k) Type
- Traditional
- Applicant
- Genesee BioMedical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/12/2016
- Days to Decision
- 103 days
- Submission Type
- Summary