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Found 9 results
510(k) Data Aggregation
K Number
K040821Device Name
COALESCENT SURGICAL U-CLIP AND ACCESSORIES
Manufacturer
COALESCENT SURGICAL
Date Cleared
2004-04-23
(24 days)
Product Code
FZP, NJU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
COALESCENT SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coalescent Surgical PG-CLIP™ and accessories are intended for endoscopic and non-endoscopic peripheral vascular and general surgical soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in peripheral vascular blood vessels, grafts and other tubular structures. The PG-CLIP is not intended for use in cardiac and/or thoracic procedures; including, but not limited to intra-cardiac and coronary artery bypass grafting (CABG) procedures.
Device Description
The Coalescent Surgical PG-CLIP™ device is a self-closing clip for peripheral vascular anastomosis and tissue approximation/attachment applications. The PG-CLIP consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may or may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools.
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K Number
K031623Device Name
MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
Manufacturer
COALESCENT SURGICAL
Date Cleared
2003-07-03
(41 days)
Product Code
FZP, NCA, NJU
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
COALESCENT SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
Device Description
The Coalescent Surgical U-CLIP™ device is a self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools.
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K Number
K024366Device Name
COALESCENT SURGICAL U-CLIP AND ACCESSORIES
Manufacturer
COALESCENT SURGICAL
Date Cleared
2003-01-17
(17 days)
Product Code
FZP
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
COALESCENT SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
Device Description
The Coalescent Surgical U-CLIP™ device is a self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel retention tools.
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K Number
K023125Device Name
COALESCENT U-CLIP- AND ACCESSORIES
Manufacturer
COALESCENT SURGICAL
Date Cleared
2002-12-18
(90 days)
Product Code
NJU
Regulation Number
878.4495Why did this record match?
Applicant Name (Manufacturer) :
COALESCENT SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coalescent Surgical U-CLIP™ and accessories is indicated for use in general soft tissue approximation and /or ligation, including use in cardiovascular procedures.
Device Description
The Coalescent Surgical U-CLIP™ device is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip (optionally containing suture) and connected to needles via flexible members (optionally including various types of suture). This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip removal devices and vessel retention tools.
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K Number
K021407Device Name
COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES
Manufacturer
COALESCENT SURGICAL
Date Cleared
2002-07-03
(61 days)
Product Code
FZP
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
COALESCENT SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The modified Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic tissue and prosthetic material approximation/attachment and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
Device Description
The modified Coalescent Surgical U-CLIP™ is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip connected to needles via flexible members. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip removal devices and vessel retention tools.
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K Number
K013664Device Name
COALESCENT SURGICAL U-CLIP
Manufacturer
COALESCENT SURGICAL
Date Cleared
2002-01-24
(79 days)
Product Code
NCA
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
COALESCENT SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic use in tissue and prosthetic material approximation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including cardiovascular and coronary artery bypass grafting procedures.
Device Description
The Coalescent Surgical U-CLIP™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The U-CLIP consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure and facilitation of an interrupted technique. The device is fabricated from standard medical and implantable grade materials.
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K Number
K012317Device Name
COALESCENT SURGICAL U-CLIP
Manufacturer
COALESCENT SURGICAL
Date Cleared
2001-08-31
(39 days)
Product Code
FZP
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
COALESCENT SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coalescent Surgical U-Clip™ is intended for endoscopic and non-endoscopic use in tissue and prosthetic material approximation and the creation of anastomoses in blood vessels, grafts and other tubular structures.
Device Description
The Coalescent Surgical U-Clip™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The U-Clip consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.
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K Number
K003958Device Name
COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE
Manufacturer
COALESCENT SURGICAL
Date Cleared
2001-02-06
(47 days)
Product Code
FZP
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
COALESCENT SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994160Device Name
COALESCENT SURGICAL SUTURED-CLIP
Manufacturer
COALESCENT SURGICAL
Date Cleared
2000-02-04
(57 days)
Product Code
FZP
Regulation Number
878.4300Why did this record match?
Applicant Name (Manufacturer) :
COALESCENT SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Coalescent Surgical Sutured-Clip™ is intended for endoscopic and non-endoscopic use in the creation of anastomoses in blood vessels, grafts and other tubular structures.
Device Description
The Coalescent Surgical Sutured-Clip™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The Sutured-Clip consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.
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