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
- K004012IMPRA CARBOFLO EPTFE VASCULAR GRAFTS2Cleared 510(K)
- K000504ADVANTA SUPER SOFT GRAFT2Cleared 510(K)
- K992958ADVANTA GRAFT (<6MM)2Cleared 510(K)
- K991683PTFE RINGED GORE-TEX VASCULAR GRAFT2Cleared 510(K)
- K992441ADVANTA GRAFT2Cleared 510(K)
- K984183PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 314512Cleared 510(K)
- K983769DISTAFLO BYPASS GRAFT2Cleared 510(K)
- K981076VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT2Cleared 510(K)
- K964877IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT2Cleared 510(K)
- K960766MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT2Cleared 510(K)
- K955533DIASTAT VASCULAR ACCESS GRAFT2Cleared 510(K)
- K953287DIASTAT VASCULAR ACCESS GRAFT2Cleared 510(K)
- K944844BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT2Cleared 510(K)
- K933391ATRIUM'S HYBRID PTFE2Cleared 510(K)
- K940824DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III2Cleared 510(K)
- K934726FEP RINGED GORE-TEX VASCULAR GRAFT2Cleared 510(K)
- K924360IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS)2Cleared 510(K)
- K881732GORE-TEX VASCULAR GRAFT2Cleared 510(K)
- K842144GORE-TEX VASCULAR GRAFT, FEP-RINGED2Cleared 510(K)
- K821826FEP-RINGED GORE-TEX@ VASCULAR GRAFT2Cleared 510(K)
- K791810VASCULAR GRAFT PROST. OF EXPANDED PTFE2Cleared 510(K)
- 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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DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K940824
- 510(k) Type
- Traditional
- Applicant
- W.L. GORE & ASSOCIATES,INC
- Country
- United States
- FDA Decision
- Substantially Equivalent - Subject to Tracking & Post-Market Surveillance
- Decision Date
- 5/4/1994
- Days to Decision
- 118 days
- Submission Type
- Summary