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Found 4 results
510(k) Data Aggregation
K Number
K210629Device Name
SecurAcath
Manufacturer
Interrad Medical Inc
Date Cleared
2021-04-12
(41 days)
Product Code
OKC, KMK
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
Interrad Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SecurAcath device is intended to secure catheters by means of a subcutaneous anchor.
The SecurAcath Device is indicated for catheter securement to the access site by means of subcutaneous anchors in:
a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short and long-term securement of percutaneous indwelling catheter for abscess/general drainage
Device Description
The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.
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K Number
K180994Device Name
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
Manufacturer
Interrad Medical Inc
Date Cleared
2019-07-09
(449 days)
Product Code
KMK, OKC
Regulation Number
880.5210Why did this record match?
Applicant Name (Manufacturer) :
Interrad Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SecurAcath device is indicated for catheter securement to the access site by means of subcutaneous anchors in:
a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short or long-term securement of percutaneous indwelling catheters for abscess/general drainage
Device Description
The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.
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K Number
K180769Device Name
SecurAcath
Manufacturer
Interrad Medical Inc
Date Cleared
2018-06-26
(95 days)
Product Code
OKC, KMK
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
Interrad Medical Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SecurAcath device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.
Device Description
The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.
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K Number
K120935Device Name
SECURACATH
Manufacturer
INTERRAD MEDICAL INC
Date Cleared
2012-04-27
(30 days)
Product Code
OKC, KMK
Regulation Number
880.5970Why did this record match?
Applicant Name (Manufacturer) :
INTERRAD MEDICAL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SecurAcath Device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.
Device Description
The SecurAcath is a single use, sterile device for securing indwelling catheters. The device is a standalone accessory to percutaneous indwelling catheters and consists of a subcutaneous anchor that is deployed in the subcutaneous space at the catheter access site to reduce catheter migration and pull-out.
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