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510(k) Data Aggregation
K Number
K183357Device Name
XableCath Crossing Catheter
Manufacturer
Date Cleared
2019-01-21
(48 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
XableCath, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XableCath Catheter is intended for use with a guidewire to access discrete regions of the peripheral vasculature. The XableCath™ Crossing Catheter is intended for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.
Device Description
The XableCath Crossing Catheter device is an over-the-wire (OTW) single-lumen catheter, with blunt and abrasion tip design. The catheter is offered in a product family configuration, with size models as outlined below:
Catalog Number: AbrasionTip (A), Blunt Tip (B)
Dimensions: Working Length (cm), Recommended Guidewire Inches (mm)
XC-014-065A, XC-014-065B, 65, 0.014" (0.36 mm)
XC-014-090A, XC-014-090B, 90, 0.014" (0.36 mm)
XC-014-145A, XC-014-145B, 145, 0.014" (0.36 mm)
XC-018-065A, XC-018-065B, 65, 0.018" (0.46 mm)
XC-018-090A, XC-018-090B, 90, 0.018" (0.46 mm)
XC-018-145A, XC-018-145B, 145, 0.018" (0.46 mm)
XC-035-065A, XC-035-065B, 65, 0.035" (0.89 mm)
XC-035-090A, XC-035-090B, 90, 0.035" (0.89 mm)
XC-035-145A, XC-035-145B, 145, 0.035" (0.89 mm)
The catheter shaft consists of a cortically reinforced co-polymeric material blend, with radiopague cobalt chromiumtunqsten-nickel distal tip. The proximal portion is comprised of an olefin strain relief and polycarbonate hub, which includes a female luer connection with the catheter lumen. The catheter pass-through lumen is used to advance the catheter over an appropriately sized guidewire for intravascular advancement to the target site. Component connections are ensured through inter-mechanical locks and utilization of medical grade adhesives. Catheter quidewire compatibility size/length are declared on the XableCath Crossing Catheter strain relief. All provided family member models are compatible with ≥4Fr introducer sheaths. All product configurations are provided sterile, single-use only.
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K Number
K180986Device Name
XableCath Support Catheter Product Family
Manufacturer
Date Cleared
2018-05-15
(29 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
XableCath, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XableCath catheter is intended to be used to facilitate access to discrete regions of the peripheral vasculature in conjunction with steerable guidewires. This device may be used to facilitate placement and exchange of guidewires and other interventional devices.
Device Description
Catheter, Percutaneous
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K Number
K170041Device Name
XableCath Support Catheter
Manufacturer
Date Cleared
2017-09-07
(245 days)
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
XABLECATH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XableCath catheter is intended to be used to facilitate access to discrete regions of the peripheral vasculature in conjunction with steerable guidewires. This device may be used to facilitate placement and exchange of guidewires and other interventional devices.
Device Description
The XableCath Support Catheter device is an over-the-wire (OTW) single-lumen catheter, with blunt tip design. The catheter is offered in a product family configuration, with size models as outlined in the table below:
Catalog Number Blunt Tip (B) | French Size | Working Length (cm) | Recommended Guidewire Inches (mm)
---|---|---|---
XC-014-065B | 5Fr | 65 | 0.014" (0.36 mm)
XC-014-090B | 5Fr | 90 | 0.014" (0.36 mm)
XC-014-145B | 5Fr | 145 | 0.014" (0.36 mm)
XC-018-065B | 6Fr | 65 | 0.018" (0.46 mm)
XC-018-090B | 6Fr | 90 | 0.018" (0.46 mm)
XC-018-145B | 6Fr | 145 | 0.018" (0.46 mm)
XC-035-065B | 7Fr | 65 | 0.035" (0.89 mm)
XC-035-090B | 7Fr | 90 | 0.035" (0.89 mm)
XC-035-145B | 7Fr | 145 | 0.035" (0.89 mm)
The catheter shaft consists of a cortically reinforced co-polymeric material blend, with radiopaque cobalt chromiumtungsten-nickel distal tip. The proximal portion is comprised of an olefin strain relief and polycarbonate hub, which includes a female luer connection with the catheter lumen. The catheter pass-through lumen is used to advance the catheter over an appropriately sized guidewire for intravascular advancement to the target site. Component connections are ensured through inter-mechanical locks and utilization of medical grade adhesives. Catheter quidewire compatibility size/length are declared on the XableCath Support Catheter strain relief. All provided family member models are compatible with >=4Fr introducer sheaths. All configurations are provided sterile, single-use only.
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