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510(k) Data Aggregation
K Number
K233917Device Name
ICHOR 7F Embolectomy System (ICH-7F)
Manufacturer
Date Cleared
2024-07-18
(219 days)
Product Code
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
ICHOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ICHOR 7F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The device is intended for the peripheral vasculature and is not intended for use in the coronary or neurovasculature.
Device Description
The ICHOR 7F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The System is intended for the peripheral vasculature (nominal size 4-10mm). The ICHOR 7F consists of four components: the Introducer Sheath, the Dilator, the Guide Catheter, and the Balloon Catheter. The outermost catheter is the Introducer Sheath which travels to the occlusion site over the Dilator. The Introducer Sheath is placed proximal to the occlusion and anchored into place by inflating the occluding balloon located at the distal tip. The balloon on the Introducer Sheath also serves to occlude flow. The Guide Catheter, composed of the Basket Catheter telescoped within the Guide Catheter Sheath, is passed through the Introducer Sheath. When in place, the Guide Catheter Sheath, which serves as the capturing sleeve, is retracted proximally allowing a nitinol basket to expand within the vasculature proximal to the occlusion. The Balloon Catheter is passed through the Guide Catheter and extended past the occlusion. The treatment balloon is inflated distal to the occlusion, and the Balloon Catheter is pulled proximally towards the basket until the occlusion is contained inside the basket. If desired the Guide Catheter can introduce aspiration to apply negative pressure to guide embolic material into the basket. The accessories include two 1 cc syringes, two Tuohy Borst with extension lines, two three-way stopcocks, two one-way stopcocks, and one stylet.
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K Number
K230743Device Name
ICHOR 14F Embolectomy System
Manufacturer
Date Cleared
2023-09-05
(173 days)
Product Code
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
ICHOR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ICHOR 14F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from venous blood vessels. The System is intended for the peripheral vasculature and is not intended for use in the coronary or neurovasculature.
Device Description
The ICHOR 14F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The System is intended for the peripheral venous vasculature (nominal size 8-14mm).
- The System is composed of three catheters: (1) Introducer Sheath, (2) Guide Catheter, and (3) Balloon Catheter and accessories.
- The outermost catheter is the Introducer Sheath, which travels to the occlusion site over the dilator. The Introducer Sheath is placed proximal to the occlusion and anchored into place by inflating the occluding balloon located at the distal tip. The balloon on the Introducer Sheath also serves to occlude flow.
- The Guide Catheter, composed of the Basket Catheter telescoped within the Guide Catheter Sheath, is passed through the Introducer Sheath. When in place, the Guide Catheter Sheath, which serves as the capturing sleeve, is retracted proximally allowing a nitinol basket to expand within the vasculature proximal to the occlusion.
- The Balloon Catheter is passed through the Guide Catheter and extended past the occlusion. The treatment balloon is inflated distal to the occlusion, and the Balloon Catheter is pulled proximally towards the basket until the occlusion is contained inside the basket. If desired the Guide Catheter can introduce aspiration to apply negative pressure to guide embolic material into the basket.
- The accessories include a dilator, flush adapter, two 3cc syringes, a Tuohy Borst, and four extension lines with one-way stopcocks.
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K Number
K182167Device Name
The ICHOR Panacea Vascular Embolectomy Catheter System
Manufacturer
Date Cleared
2018-12-21
(133 days)
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
ICHOR Vascular, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Panacea embolectomy system is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The device is intended for the peripheral vasculature, and is not intended for use in the coronary or neurovasculature.
Device Description
The fundamental mechanism of action is temporary vessel occlusion combined with mechanical balloon embolectomy and aspiration through a guide catheter. The sheath provides vessel access. The occlusion balloon catheter is intended for temporary vessel occlusion and the guide catheter functions to remove emboli and thrombi. The devices are provided sterile, non-pyrogenic, and intended for single use only.
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