Search Results
Found 2 results
510(k) Data Aggregation
K Number
K042449Device Name
DOLPHIN INFLATION DEVICE
Manufacturer
SEDAT S.A.
Date Cleared
2005-04-18
(221 days)
Product Code
MAV, DTL, REG
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
SEDAT S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DOLPHIN Inflation Device is intended for use during cardiovascular procedures to create, maintain and monitor pressure in the balloon catheter.
Device Description
DOLPHIN is a single-use, sterile, and ergonomically designed inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two components - the inflation device and large volume syringe (30 cc).
The manually operation of the DOLPHIN is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure even if the user lets go of the device.
Instantaneous deflation, regardless of balloon size, is made possible by the release of the dual locks located on device as well as a large, 30 cc syringe that is sold with each Dolphin Inflation Device.
All the while during inflation or deflation pressure is displayed and can be monitored on a large analog gauge mounted on top of the device.
Ask a Question
K Number
K040498Device Name
MYSHELL
Manufacturer
SEDAT S.A.
Date Cleared
2004-07-02
(127 days)
Product Code
DTL
Regulation Number
870.4290Why did this record match?
Applicant Name (Manufacturer) :
SEDAT S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MYSHELL is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (<.098") during interventional procedures.
The 3-way stopcock, Alligatork and guidewire introducer are accessories used in conjunction with MYSHELL to facilitate interventional procedures.
MYSHELL and its accessories are indicated for assisting, manipulating and maintaining a seal around diagnostic/interventional devices with an outside diameter <9F (.098") used in interventional procedures.
Device Description
MYSHELL is an ergonomically designed y-connector/hemostatic valve that accepts materials up to 9F in size (<.098").
The watertight double hemostatic silicone valve is manipulated by a valve opening mechanism on the external body of MYSHELL. The opening mechanism allows for precise control of the internal valve: press gradually on the mechanism for a controlled opening, push the mechanism entirely in for a complete and locked opening, or completely close the valve by depressing on the mechanism in its locked position.
Ask a Question
Page 1 of 1