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510(k) Data Aggregation
K Number
K082870Device Name
VTI INTRAOPERATIVE DOPPLER SYSTEMS
Manufacturer
VASCULAR TECHNOLOGY INCORPORATED
Date Cleared
2008-10-28
(29 days)
Product Code
DPW
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
VASCULAR TECHNOLOGY INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VTI Intraoperative Doppler Systems are intended for the intraoperative and transcutaneous evaluation of blood flow.
Indications for Use form filed with the FDA for the VTI Doppler Probes lists the clinical applications as Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
Device Description
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K Number
K031091Device Name
VTI 20 MHZ GATED DOPPLER
Manufacturer
VASCULAR TECHNOLOGY INCORPORATED
Date Cleared
2003-04-23
(16 days)
Product Code
DPW
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
VASCULAR TECHNOLOGY INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VTI 20 MHz Gated Doppler is intended for the intraoperative and transcutaneous evaluation of blood flow.
Device Description
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K Number
K002990Device Name
VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001
Manufacturer
VASCULAR TECHNOLOGY INCORPORATED
Date Cleared
2000-11-06
(42 days)
Product Code
HBL
Regulation Number
882.4460Why did this record match?
Applicant Name (Manufacturer) :
VASCULAR TECHNOLOGY INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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