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510(k) Data Aggregation
K Number
K150813Device Name
iTClamp50
Manufacturer
Date Cleared
2015-04-30
(34 days)
Product Code
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE TRAUMA CARE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iTClamp®50 is a trauma clamp device for the temporary control of severe bleeding in the extremittes, axilla, inguinal areas, scalp, and neck.
Device Description
The iTClamp50 is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp50 is a selflocking surgical clamp with suture needles that penetrate the skin to evert the skin edges (similar to sutures or staples) between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal.
The iTClamp50 controls bleeding by sealing the skin closed to apply direct pressure to the cut edges of the skin and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair.
The device is provided sterile and is for single use.
The iTClamp50 consists of the following components:
- 1) Suture needles
- 2) Tray w/Tyvek lid
- 3) Locking mechanism
- 4) Lock release mechanism
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K Number
K140805Device Name
ITCLAMP 50
Manufacturer
Date Cleared
2014-10-09
(191 days)
Product Code
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE TRAUMA CARE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iTClamp50 is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla, inguinal areas, scalp, and neck.
Device Description
The iTClamp™50 is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp50 is a selflocking surgical clamp with suture needles that penetrate the skin to evert the skin edges (similar to sutures or staples) between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal.
The iTClamp controls bleeding by sealing the skin closed to apply direct pressure to the cut edges of the skin and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair.
The device is provided sterile and is for single use.
The iTClamp consists of the following components:
- 1) Suture needles
- 2) Plastic shell
- 3) Locking mechanism
- 4) Lock release mechanism
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K Number
K132651Device Name
ITCLAMP 50
Manufacturer
Date Cleared
2013-10-28
(63 days)
Product Code
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE TRAUMA CARE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iTClamp50 is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla, inguinal areas and scalp.
Device Description
The iTClamp™50 is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp50 is a selflocking surgical clamp with suture needles that penetrate the skin to evert the skin/scalp edges (similar to sutures or staples) between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal. The iTClamp controls bleeding by sealing the skin/scalp closed to apply direct pressure to the cut edges of the skin/scalp and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair. The device is provided sterile and is for single use. The iTClamp consists of the following components: 1) Suture needles 2) Plastic shell 3) Locking mechanism 4) Lock release mechanism
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K Number
K123551Device Name
ITCLAMP 50
Manufacturer
Date Cleared
2013-05-14
(176 days)
Product Code
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE TRAUMA CARE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ITClamp™ is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla and inguinal areas.
Device Description
The ITClamp™ is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The ITClamp is a self-locking surgical clamp with suture needles that penetrate the skin to evert the skin edges between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal.
The ITClamp™ controls bleeding by sealing the skin closed to apply direct pressure and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair.
The device is provided sterile and is for single use.
The ITClamp™ consists of the following components:
1) Suture needles
2) Plastic Shell
3) Locking mechanism
4) Lock release mechanism
Ask a Question
Ask a specific question about this device
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