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510(k) Data Aggregation
K Number
K022895Device Name
ELCAM STOPCOCKS AND MANIFOLDS
Manufacturer
MEDICAL DEVICE CONSULTANTS, INC.
Date Cleared
2002-10-18
(45 days)
Product Code
FMG
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DEVICE CONSULTANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Elcam Stopcocks and Manifolds are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.
Device Description
Elcam Stopcocks and Manifolds are composed of a body with two or three ports and a handle. Each port has either a male or female connector. Male connectors also include a nut for locking over the female connector of another component. A small amount of lubricant is applied between the stopcock body and handle. Elcam Stopcocks and Manifolds will be available in a wide variety of configurations for use according to the particular situation and the clinician's preference.
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K Number
K002699Device Name
PARIETEX COMPOSITE (PCO) MESH
Manufacturer
MEDICAL DEVICE CONSULTANTS, INC.
Date Cleared
2001-02-15
(169 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DEVICE CONSULTANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002116Device Name
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
Manufacturer
MEDICAL DEVICE CONSULTANTS, INC.
Date Cleared
2000-08-09
(27 days)
Product Code
DTQ
Regulation Number
870.4220Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DEVICE CONSULTANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000551Device Name
IMAGE X-70 PLUS DENTAL X-RAY UNIT
Manufacturer
MEDICAL DEVICE CONSULTANTS, INC.
Date Cleared
2000-03-16
(27 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DEVICE CONSULTANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K974164Device Name
SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
Manufacturer
MEDICAL DEVICE CONSULTANTS, INC.
Date Cleared
1997-12-18
(43 days)
Product Code
FFK
Regulation Number
876.4480Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL DEVICE CONSULTANTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LITHOCLAST® MASTER Handpiece and the 3.2 mm probe have the same intended use as their predicate accessories, that is, for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or The 3.2 mm probe is specifically indicated for use in semirigid endoscopes. fragmenting large stones in the bladder and kidney.
Device Description
MASTER Handpiece: The MASTER Handpiece is 18 mm in diameter, 228 mm long, and is constructed of aluminum alloy. The proximal end of the handpiece is connected to the LITHOCLAST pressure regulator. The chosen treatment probe is attached to the distal end of the handpiece using a screw cap. The metal projectile inside the handpiece is driven forward by the pressure from the pressure regulator. The energy from the projectile is transmitted to the probe by a shock transmitter at the distal end of the handpiece. The handpiece is sealed at both the distal and proximal ends, which: (1) prolongs the life time of the handpiece by preventing dirt, moisture and other particles from entering the handpiece; and (2) allows for the changing of probes during a treatment without the risk of breaking sterility.
3.2 mm Probe: The 3.2 mm probe is a rigid Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece to the target stone. The probe is reusable and may be sterilized by steam sterilization according to standard hospital procedures.
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