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510(k) Data Aggregation
K Number
K150187Device Name
ELITECROSS Support Catheter
Manufacturer
Cordis Corporation, A Johnson & Johnson Company
Date Cleared
2015-05-19
(112 days)
Product Code
PDU, KRA
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
**Cordis Corporation, A Johnson **& Johnson Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cordis ELITECROSS™ Support Catheter is intended to facilitate the intraluminal placement of diagnostic/ interventional devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, and to deliver saline or contrast medium. Additionally, ELITECROSS™ can be used as an accessory with the FRONTRUNNER® XP CTO Catheter.
Device Description
The ELITECROSS™ Support Catheter is a single-use, 5F sheath-compatible sterile catheter designed to provide additional support to the distal portion of ancillary diagnostic/interventional devices, including the FRONTRUNNER® XP CTO Catheter, as well as to deliver saline or contrast medium. After crossing the occlusion with the ancillary device, the ELITECROSS™ may be used to facilitate placing a guide wire across the occlusion.
The ELITECROSS™ Support Catheter device is a single lumen torqueable tube containing a full-length PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating on the distal 40 cm of the catheter body. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under fluoroscopy. The ELITECROSS™ Support Catheter will be available in various configurations and several lengths. The ELITECROSS™ Support Catheter is provided sterile (by EO) and intended for single use only.
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K Number
K150836Device Name
OUTBACK Elite Re-Entry Catheter
Manufacturer
CORDIS CORPORATION, A JOHNSON & JOHNSON CO.
Date Cleared
2015-04-29
(30 days)
Product Code
PDU
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
**CORDIS CORPORATION, A JOHNSON **& JOHNSON CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OUTBACK Elite Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The OUTBACK Elite Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.
Device Description
The OUTBACK® Elite Re-Entry Catheter is a single-use device designed to facilitate placement and positioning of guidewires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The OUTBACK® Elite Re-Entry Catheter is supplied sterile and is available in two useable lengths.
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