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
- K240775PeriBeam® Pericardial Membrane2Cleared 510(K)
- K200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch2Cleared 510(K)
- K200566ADAPT Tissue2Cleared 510(K)
- K162506PhotoFix Decellularized Bovine Pericardium2Cleared 510(K)
- K162579VascuCel2Cleared 510(K)
- K152127CorMatrix Tyke2Cleared 510(K)
- K151865PremiPatch PTFE Pledget2Cleared 510(K)
- K142447PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch2Cleared 510(K)
- K142461VASCU-GUARD Peripheral Vascular Patch2Cleared 510(K)
- K140789CORMATRIX ECM FOR VASCULAR REPAIR2Cleared 510(K)
- K130872CARDIOCEL2Cleared 510(K)
- K122306SYNOVIS COLLAGEN MATRIX (TBD)2Cleared 510(K)
- K122105SMI CARDIOVASCULAR PATCH2Cleared 510(K)
- K112683SMI CARDIOVASCULAR PACH2Cleared 510(K)
- K111187PATCH, PLEDGET AND INTRACARDIAC2Cleared 510(K)
- K101740ALBOSURE POLYESTER VASCULAR PATCH2Cleared 510(K)
- K101866CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH2Cleared 510(K)
- K090637CARDIO-WRAP2Cleared 510(K)
- K091626CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH2Cleared 510(K)
- K082139EDWARDS BOVINE PERICARDIAL PATCH, MODEL 47002Cleared 510(K)
- K081438MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT2Cleared 510(K)
- K063349CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR2Cleared 510(K)
- K060396IVENA VASCULAR PATCH2Cleared 510(K)
- K052416PERIPRO PATCH2Cleared 510(K)
- K051405REGENSIS PERICARDIAL PATCH2Cleared 510(K)
- K041736PFA PATCH2Cleared 510(K)
- K041716PTFE FELTS AND PLEDGETS2Cleared 510(K)
- K040415PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT2Cleared 510(K)
- K040162CORRESTORE PATCH SYSTEM2Cleared 510(K)
- K031948PERIPATCH SHEET, MODELS 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P162Cleared 510(K)
- K031586CORRESTORE PATCH SYSTEM2Cleared 510(K)
- K022093CHASE CARDIOVASCULAR PATCH KIT2Cleared 510(K)
- K021129CHARE CARIOVASCULAR PATCH2Cleared 510(K)
- K020233CHASE CARDIOVASCULAR PATCH KIT2Cleared 510(K)
- K020132CHASE CARDIOVASCULAR PATCH KIT2Cleared 510(K)
- K011487CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS2Cleared 510(K)
- K012098PRECLUDE PERICARDIAL MEMBRANE2Cleared 510(K)
- K012248CHASE CARDIOVASCULAR PATCH2Cleared 510(K)
- K003467CHASE CARDIOVASCULAR PATCH2Cleared 510(K)
- K001785SURGISIS PERIPHERAL VASCULAR PATCH2Cleared 510(K)
- K003070ETHIBOND EXCEL VALVE LOOP SUTURE2Cleared 510(K)
- K001662CHASE CARDIOVASCULAR PATCH2Cleared 510(K)
- K994032FLUORO-TEX CARDIOVASCULAR PATCH2Cleared 510(K)
- K993288SULZER CARBOMEDICS CARDIOFIX PERICARDIUM2Cleared 510(K)
- K992776UNI-GRAFT K DV PATCH2Cleared 510(K)
- K984526ACUSEAL CARDIOVASCULAR PATCH2Cleared 510(K)
- K983602CV PERI-GUARD AND VASCU-GUARD2Cleared 510(K)
- K982810SHELHIGH NO-REACT VASCUPATCH2Cleared 510(K)
- K974914SHELHIGH NO-REACT PERICARDIAL PATCHES2Cleared 510(K)
- K972201PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE2Cleared 510(K)
- K971726CV PERI-GUARD - CARDIOVASCULAR PATCH2Cleared 510(K)
- K973178FLUORO-TEX SURGICAL MEMBRANE2Cleared 510(K)
- K963967GLYCAR PERICARDIAL PATCH2Cleared 510(K)
- K963368GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE2Cleared 510(K)
- K964467SHELHIGH PERICARDIAL PATCH2Cleared 510(K)
- K963611VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH2Cleared 510(K)
- K962342HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH2Cleared 510(K)
- K955349HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC2Cleared 510(K)
- K953425POLYETHYLENE TEREPHTHALATE (PET) PLEDGET2Cleared 510(K)
- K953289TETRAFLUOROETHYLENE (TFE) POLYMER PLEDGET2Cleared 510(K)
- K943736CVPRO CARDIOVASCULAR PATCH2Cleared 510(K)
- K942010VASCU-GUARD2Cleared 510(K)
- K940906GORE-TEX CARDIOVASCULAR PATCH2Cleared 510(K)
- K930950GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE2Cleared 510(K)
- K931386HEMASHIELD MICROVEL/WOVEN DOUBLE VELOUR FABRIC2Cleared 510(K)
- K921659ULTRA LOW POROSITY DACRON WOVEN PATCH2Cleared 510(K)
- K921895TISSUE PATCH, TISSUE GRAFT2Cleared 510(K)
- K905073CARDIOVASCULAR REPAIR PATCH2Cleared 510(K)
- K914450GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE2Cleared 510(K)
- K914448GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE2Cleared 510(K)
- K912107GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM2Cleared 510(K)
- K910464GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE2Cleared 510(K)
- K905496WOVEN AND KNITTED MINICRIMP CAROTID PATCH FABRICS2Cleared 510(K)
- K881508OCHSNER & MICRON FABRIC PATCH2Cleared 510(K)
- K842066PERI-GUARD PERICARDIAL PATCH2Cleared 510(K)
- K833763PERICARDIAL PATCH2Cleared 510(K)
- K840262HANCOCK PERICARDIAL PATCH2Cleared 510(K)
- K831516GORE-TEX SURGICAL MEMBRANE2Cleared 510(K)
- K833021PERI-GUARD PERICARDIAL PATCH-HERNIA2Cleared 510(K)
- K830863HANCOCK PERICARDIAL PATCH2Cleared 510(K)
- K830806VASCULAR GRAFT/BIFURCATED/FEP-RINGED2Cleared 510(K)
- K823345PATCH2Cleared 510(K)
- K821717GORE-TES EXPANDED PTFE PATCH2Cleared 510(K)
- K821532PERIGUARD PERICARDIAL PATCH2Cleared 510(K)
- K811841GORE-TEX CARDIOVASCULAR PATCH2Cleared 510(K)
- K812254DACRON PLEDGET SUTURE BUTTRESS2Cleared 510(K)
- K811872TEFLON PLEDGET SUTURE BUTTRESS2Cleared 510(K)
- K801764IONESCU-SHILEY PERICARDIAL PATCH2Cleared 510(K)
- K791792SCI MED PERICARDIAL SUBSTITUTE2Cleared 510(K)
- K770835PATCH FABRIC2Cleared 510(K)
- K760516FELT, SURGICAL DACRON2Cleared 510(K)
- 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
- 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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SHELHIGH NO-REACT PERICARDIAL PATCHES
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K974914
- 510(k) Type
- Traditional
- Applicant
- SHELHIGH, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/3/1998
- Days to Decision
- 177 days
- Submission Type
- Summary