Search Results
Found 3 results
510(k) Data Aggregation
K Number
K972814Device Name
LOCATOR MODEL 4036
Manufacturer
PACESETTER, INC.
Date Cleared
1998-02-23
(209 days)
Product Code
DTB
Regulation Number
870.3680Why did this record match?
Applicant Name (Manufacturer) :
PACESETTER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Locator™ Steerable Stylet is intended for use when implanting the Pacesetter Tendril® model 1188 T/K pacemaker leads, in 46, 52, and 58 cm lengths in patients requiring long-term lead implantation to provide cardiuc pacing.
Device Description
The Locator™ steerable stylet consists of a curved wire that fits inside a thin-walled tube. Sliding the tube relative to the wire by manipulating the handle allows different curvatures on the stylet, and thus the lead, to be obtained.
Ask a Question
K Number
K960854Device Name
SIEMENS SERVO ULTRA NEBULIZER 345
Manufacturer
PACESETTER, INC.
Date Cleared
1996-12-23
(297 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
PACESETTER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Siemens Model 345 Ultra Nebulizer is to nebulize liquid medication for introduction into the patient's airway via an endotracheal tube. It can be used on any patient for whom the use of the Siemens Servo Ventilator 300 is indicated, in any ventilatory mode appropriate for the patient.
Device Description
The Servo Ultra Nebulizer 345 (SUN 345) is an accessory to the Servo Ventilator 300 that is used to nebulize medication during ventilator treatment. An ultrasonic nebulizer similar to those commonly marketed as a component of home "medication inhaler" devices has been adapted for use in the patient circuit of the Servo Ventilator. The ultrasonic nebulizer does not add any gas volume to the circuit, so that readings and settings on the ventilator are unaffected. The SUN 345 medication cup holds 10 ml of liquid, which is nebulized at a rate of 0.3 ml/min at 0.5 1/min gas flow. The mass median diameter of particles is 4.0 um.
Ask a Question
K Number
K954714Device Name
AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)
Manufacturer
PACESETTER, INC.
Date Cleared
1996-02-01
(122 days)
Product Code
DTB
Regulation Number
870.3680Why did this record match?
Applicant Name (Manufacturer) :
PACESETTER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1