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Found 3 results
510(k) Data Aggregation
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?
Product Code :
KMK
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
K981860Device Name
A P HARNESS
Manufacturer
PARAWORKS ENTERPRISE, LTD.
Date Cleared
1999-06-03
(372 days)
Product Code
KMK
Regulation Number
880.5210Why did this record match?
Product Code :
KMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AP Harness is to be used as a safety line between a patient and a medical machine which are connected by a medical line, (ie IV tubing, oxygen tubing, enteral tubing, etc. ). This device would be used when the patient or caregiver cannot maintain an adequate level of safety for an important catheter or other medical line.
Device Description
The A.P. Harness System facilitates increased safety and comfort of the active child or other patient while he/she is hooked-up to TPN, IV, enteral tube feed or other medical lines. This safety is accomplished by providing the maximum distance between the child and pump stand, determined by the length in the medical lines. This allows the child better access to his/her environment. The harness also limits kinking and subsequent occlusion in the medical lines. This frees the child from interruptions in play, while the caregiver searches for the location of an occlusion in the medical lines. Another benefit is increased safety and lowered stress for the caregiver. This means the supervision of the medical lines is done less intensively, and therefore the caregiver's attention can be directed to the child as a whole person and not just as a patient.
This system is comprised of a harness, a tether strap, an anchor strap, and a zipper sleeve. It is equipped with buckles that are small, low profile, strong, and secure. The shoulder straps are moveable along the chest strap; this facilitates infinite adjustability for a growing patient or for multiple patient use. The chest strap is worn directly underneath the axillas (armpits), which facilitates unhindered diaper changes and avoids soiling. The harness's location high on the chest puts the minimum amount of restriction on the respiratory system, as well as keeping access for common medical evaluations and nursing procedures. The chest strap is made of soft tubular webbing, which contours to the patients chest, preventing abrasion and pinching.
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K Number
K963365Device Name
MULTI-PURPOSE MEDICAL TUBE HOLDER
Manufacturer
BYRD MEDICAL DEVICES, INC.
Date Cleared
1996-10-11
(45 days)
Product Code
KMK
Regulation Number
880.5210Why did this record match?
Product Code :
KMK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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