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510(k) Data Aggregation
K Number
K200190Device Name
ScalpelCric
Manufacturer
VBM Medizintechnik GmbH
Date Cleared
2020-10-30
(277 days)
Product Code
BWC, JOH, OGP, PRI
Regulation Number
868.5090Why did this record match?
Applicant Name (Manufacturer) :
VBM Medizintechnik GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Emergency airway access via the cricothyroid membrane. Life-threatening dyspnoea that cannot be controlled in any other way.
Device Description
Surgical Cricothyrotomy set for securing the airway in case of upper airway obstruction, respectively as "Ultima Ratio" if all other attempts to ventilate the patient failed. The set consists of scalpel, bougie, tube, extension tube with swivel connector, syringe and necktape.
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K Number
K112783Device Name
MANUJET III
Manufacturer
VBM MEDIZINTECHNIK GMBH
Date Cleared
2011-12-22
(87 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
VBM MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Designed to provide transtracheal ventilation in specific emergency situations of upper airway obstruction, used in conjunction with a transtracheal catheter, or a cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation.
Device Description
Not Found
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K Number
K955461Device Name
TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
Manufacturer
VBM MEDIZINTECHNIK GMBH
Date Cleared
1997-03-19
(476 days)
Product Code
BTO
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
VBM MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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