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
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- DRKDc-Defibrillator, High Energy, (Including Paddles)3Product Code
- DRLTester, Defibrillator2Product Code
- DRMCompressor, Cardiac, External2Product Code
- DRNDevice, Counter-Pulsating, External2Product Code
- DROPacemaker, Cardiac, External Transcutaneous (Non-Invasive)2Product Code
- K012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-852Cleared 510(K)
- K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES2Cleared 510(K)
- K000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 204132Cleared 510(K)
- K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT2Cleared 510(K)
- K983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)2Cleared 510(K)
- K974034PORTABLE INTENSIVE CARE UNIT2Cleared 510(K)
- K962547CARDIOSERV P2Cleared 510(K)
- K963120RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM2Cleared 510(K)
- K961138ESORT II + 400 SERIES MONITOR2Cleared 510(K)
- K951593LIFEPAK 112Cleared 510(K)
- K950856ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D20002Cleared 510(K)
- K950483HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR2Cleared 510(K)
- K926175K-DEFIB/PACE CARBON ELECTRODE2Cleared 510(K)
- K915757MODELS M1722A, M1723A, M1724A DEFIBRILLATORS2Cleared 510(K)
- K915328GEL-TAC2Cleared 510(K)
- K914955K-DEFIB/PACE ELECTRODE2Cleared 510(K)
- K912599QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC2Cleared 510(K)
- K911956ZOLL PD-1400 PACER/DEFIBRILLATOR2Cleared 510(K)
- K910661MODEL 205 SHOCK-TRODE2Cleared 510(K)
- K903437DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER2Cleared 510(K)
- K894492NKA MODEL SEC-3102 CARDIAC STIMULATOR2Cleared 510(K)
- K894588DEFIB/PACING PADS2Cleared 510(K)
- K895728R2 PACE ADAPTOR CABLE, MODEL 1962Cleared 510(K)
- K895729R2 PACE PAD, MODEL 4802Cleared 510(K)
- K885166ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES2Cleared 510(K)
- K885171MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE2Cleared 510(K)
- K880932MRL PACETTE, 450SLL2Cleared 510(K)
- K884532TRIAD-EP II, PUSHBUTTON, CABLE INPUT2Cleared 510(K)
- K884530TRIAD-EP II, PLATE INPUT2Cleared 510(K)
- K883304TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY2Cleared 510(K)
- K883178TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE2Cleared 510(K)
- K883523TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE2Cleared 510(K)
- K883121QUIK-PACE II ELECTRODES2Cleared 510(K)
- K883375MODEL #918 MULTI-PADS2Cleared 510(K)
- K882338MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE2Cleared 510(K)
- K882168EXTERNAL PACEMAKER 2000 (EP2000)2Cleared 510(K)
- K880936TRIAD-EP2Cleared 510(K)
- K874447DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC2Cleared 510(K)
- K871751QUIK-PACE NONINVASIVE PACEMAKER2Cleared 510(K)
- K874090300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER2Cleared 510(K)
- K873402ZOLL NTP-1200 PACER/DEFIBRILLATOR2Cleared 510(K)
- K872778PACESTART2Cleared 510(K)
- K872368MODIFIED VERSA STIM ELECTRODE LINE2Cleared 510(K)
- K872012LECTEC NON-INVASIVE PACING ELECTRODE2Cleared 510(K)
- K871971MODIFIED PACE*AID MODEL 532Cleared 510(K)
- K871538STAT-PAD (TM)2Cleared 510(K)
- K871569MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR2Cleared 510(K)
- K871176PACE 10 NON-INVASIVE EXTERNAL PACEMAKER2Cleared 510(K)
- K864985DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE2Cleared 510(K)
- K864989ETP 180A NON-INVASIVE EXTERNAL PACEMAKER2Cleared 510(K)
- K864988ETP 180E NON-INVASIVE EXTERNAL PACEMAKER2Cleared 510(K)
- K864987DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE2Cleared 510(K)
- K864986ETP 300 NON-INVASIVE EXTERNAL PACEMAKER2Cleared 510(K)
- K863547MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE2Cleared 510(K)
- K862298ALTERNATE SIZE E-Z-PACE ELECTRODE2Cleared 510(K)
- K854196DCI MODEL EP-2 CLINICAL STIMULATOR2Cleared 510(K)
- K860551ETP 180 CARDIAC PACEMAKER (EXTERNAL)2Cleared 510(K)
- K860283AMI CARDIO-PAD2Cleared 510(K)
- K855015NONINVASIVE TEMP. PACEMAKER NTP-10002Cleared 510(K)
- K854924AMI E-Z-PACE ELECTODE2Cleared 510(K)
- K854853NI-PACER 12Cleared 510(K)
- K854117AMENDMENT LIFEPAK 8, NPN 0522Cleared 510(K)
- K854233CMI 30002Cleared 510(K)
- K853732LIFEPAK 8 MODIFICATION2Cleared 510(K)
- K850812EMERGIPACE - EXTERNAL PACEMAKER2Cleared 510(K)
- K852958PACEPAC2Cleared 510(K)
- K850791MDI 2000 - PULSE GENERATOR2Cleared 510(K)
- K851248AMENDMENT LIFEPAK 100, NPN 0452Cleared 510(K)
- K851247AMENDMENT LIFEPAK 200, NPN 0462Cleared 510(K)
- K850596PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &2Cleared 510(K)
- K850170HEART AID MODEL 972Cleared 510(K)
- K844811PACE AID MODEL 532Cleared 510(K)
- K843547PACE *AID MODEL 522Cleared 510(K)
- K843358HEART-AID MODEL 802Cleared 510(K)
- K840353PACEMAKER PULSE GENERATOR W/ELECTRODE2Cleared 510(K)
- K840047LIFEPAK 7D2Cleared 510(K)
- K834262TRANS-PACE2Cleared 510(K)
- K832876LIFEPAK 7P2Cleared 510(K)
- K822246NONINVASIVE TEMPORARY PACEMAKER2Cleared 510(K)
- K821673HEART*AID, ALS, MODEL 952Cleared 510(K)
- K821152HEART AID #902Cleared 510(K)
- K820609HEART *AID, #802Cleared 510(K)
- K820507PACE* AID MODEL 502Cleared 510(K)
- K813553PACE *AID2Cleared 510(K)
- DRPTourniquet, Automatic Rotating2Product Code
- DWJSystem, Thermal Regulating2Product Code
- DXECatheter, Embolectomy2Product Code
- DXFCatheter, Septostomy2Product Code
- JOWSleeve, Limb, Compressible2Product Code
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)2Product Code
- LHXTrousers, Anti-Shock2Product Code
- LIXAid, Cardiopulmonary Resuscitation2Product Code
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous2Product Code
- MKJAutomated External Defibrillators (Non-Wearable)3Product Code
- MMXDevice, Percutaneous Retrieval2Product Code
- MPCAtrial Defibrillator3Product Code
- MPDAuxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator2Product Code
- MPEAuxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker2Product Code
- NSAOver-The-Counter Automated External Defibrillator3Product Code
- NZEHyperthermia Monitor2Product Code
- PJBCatheter Remote Control System2Product Code
- PLAEsophageal Thermal Regulation And Gastric Suctioning Device2Product Code
- PMJCpr Aid Feedback Device (No Software)2Product Code
- PMKCpr Aid Device Without Feedback1Product Code
- PPSSleeve, Head And Neck, Compressible2Product Code
- QEWPeripheral Mechanical Thrombectomy With Aspiration2Product Code
- QEXCoronary Mechanical Thrombectomy With Aspiration2Product Code
- QEYMechanical Thrombolysis Catheter2Product Code
- QEZAspiration Thrombectomy Catheter2Product Code
- QLZSeptostomy Catheter, Reprocessed2Product Code
- QMSAdjunctive Open Loop Fluid Therapy Recommender2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ChemistryReview Panel
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- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
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- General and Plastic SurgeryReview Panel
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- UnknownReview Panel
GEL-TAC
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K915328
- 510(k) Type
- Traditional
- Applicant
- KATECHO, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/29/1992
- Days to Decision
- 216 days
- Submission Type
- Statement