Search Results
Found 3 results
510(k) Data Aggregation
K Number
K962700Device Name
VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT
Manufacturer
VASAMEDICS, L.L.C.
Date Cleared
1997-04-09
(271 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Applicant Name (Manufacturer) :
VASAMEDICS, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The probes kits are intended for extravascular monitoring of microcirculation blood flow in buried tissues, specifically, in monitoring cerebral blood flow in patients at risk of cerebral ischemia.
Device Description
The Ventraflo Catheter/Probe is a standard ventricular catheter with a laser Doppler blood perfusion probe embedded into the side wall of the Catheter. So when the catheter is placed within a brain ventrical the clinician will be able to use the catheter as a CSF drain . measure intracranial ventricular pressure. If connected to an external transducer and measure parenchymal blood flow simultaneously.
Ask a Question
K Number
K961368Device Name
TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT
Manufacturer
VASAMEDICS, L.L.C.
Date Cleared
1996-10-11
(185 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Applicant Name (Manufacturer) :
VASAMEDICS, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The probes kits are intended for extravascular monitoring of microcirculation blood flow in buried tissues, specifically, in monitoring cerebral blood flow in patients at risk of cerebral ischemia.
Device Description
The Model BPM2 is a Laser Doppler Blood Perfusion Monitor, which is used to measure microcirculatory blood flow in a variety of clinical applications. Permission to market the BPM2 was granted by FDA on February 13, 1990 (Ref. K896515). The Model SUPR-434 Blunt Needle Probe is a single use fiber optic probe designed for use with the BPM2. These probes are labeled so as to be used for monitoring buried tissue, such as brain parenchyma during and following neurosurgical procedures. Permission to market the Model SUPR-434 ( Note: the SUPR-434 Blunt needle probes model names have since been changed to Trimflo 4314, 4316, 4364 and 4366) was granted on March 21, 1996 (Ref. K951832).
Ask a Question
K Number
K951832Device Name
LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433
Manufacturer
VASAMEDICS, L.L.C.
Date Cleared
1996-03-21
(336 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Applicant Name (Manufacturer) :
VASAMEDICS, L.L.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Single Use Probes are intended for extravascular monitoring of microcirculation blood flow in buried tissues. An example of this application is the monitoring of buried muscle or esophagus following free muscle transfer or esophageal reconstruction, Another example is monitoring soft tissue microcirculation following reconstructive surgery, such as in oral and facial reconstruction. Yet another example is monitoring cerebral blood flow during and following neurosurgery for head trauma.
Device Description
The Model BPM2 is a Laser Doppler Blood Perfusion Monitor, which is used to measure microcirculatory blood flow in a variety of clinical applications. Permission to market the BPM2 was granted by FDA on February 13, 1990 (Ref K896515). The Model P-433 Needle Probe, Model PR-434 Implantable Prism Probe, and Model P-440 Implantable Soflex Probe are fiber optic probes designed for use with the BPM- These probes are labelled so as to be used for monitoring buried tissue, such as buried muscle following free muscle transfers and cerebral cortex following neurosurgical procedures. Permission to market the Model PR-434 and Model P-433 probes was granted by FDA on September 19, 1988 (Ref K875179). Permission to market the P-440 was granted by FDA on December 12, 1991 (Ref K912446).
The single use probes, SUP-440 Disposable Flat Probe, SUP-433 Disposable Right Angle Needle Probe, and SUPR-434 Disposable Blumt End Needle probe are also fiber optic probes designed for use with the BPM2 They connect to the BPM2 Probe Connector Port on the BPM front panel via a fiber optic interface cable. The tip of the SUP-440 Disposable Flat Profile Probe is similar to the P-440 Soflex Probe in that it includes the termination of the optical fiber which provides right angle light emission, and an outer encapsulation of soft, flexible material. The tip of the SUP-433 Disposable Right Angle Needle Probe and the SUPR-434 Disposable Blunt End Needle Probe are similar to the P-433 Needle Probe in that it includes the termination of the optical fiber in a stainless steel tube and similar to the PR-434 Implantible prism probe in that the probes provide right angle light emission.
Ask a Question
Page 1 of 1