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510(k) Data Aggregation
K Number
K991235Device Name
SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)
Manufacturer
LUDLOW TECHNICAL PRODUCTS
Date Cleared
1999-07-08
(87 days)
Product Code
KXO
Regulation Number
884.2700Why did this record match?
Applicant Name (Manufacturer) :
LUDLOW TECHNICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Softrans Temp™ IUPC System may be used during the interpartum period to monitor intrauterine pressure, to monitor intrauterine temperature, to amnioinfuse or to perform amniotic fluid sampling.
Device Description
An intrauterine catheter with a pressure transducer at the tip, a thermistor located near the tip, a port for amnioinfusion and amniotic fluid sampling, signal wires, and an introducer which is removed after placement. System includes a reusable cable that contains a rezero mechanism, cable check and temperature display unit. An attachment strap is provided.
Catheters are packaged within a PETG tray with a heat sealed tyvek lid. Unit of sale is a case of 10 IUPC's.
Cables are packaged in protective wrap and corrugated shippers.
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K Number
K973110Device Name
LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORD
Manufacturer
LUDLOW TECHNICAL PRODUCTS
Date Cleared
1997-10-21
(62 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
LUDLOW TECHNICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ProCam Medical Pediatric Dispersive Electrode is indicated for use in monopolar electrosurgical applications as a non-sterile, disposable device, for single patient use, only. It is intended to disperse the current as it is removed from the patient during the electrosurgical process. By connecting to the electrosurgical generator, via the pre-attached cable or re-useable cable, the circuit is completed causing successful cutting or coagulation in the patient. This electrode is intended for use in electrosurgery on pediatric patients weighing 25 lbs. or less and with the generator power settings less than 150 watts. The Pediatric Dispersive Electrode is not indicated for use for high-powered procedures such as transurethral resection (TUR). The device will work with any standard generator.
Device Description
The function of the Ludlow Technical Products pediatric ESD electrodes is to complete the electrosurgical circuit between the patient, the active electrode, and the generator. The products are the same in their construction using conductive adhesive hydrogel along with a foil/polyester conductor plate and a foam insulation backing.
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K Number
K972646Device Name
AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES
Manufacturer
LUDLOW TECHNICAL PRODUCTS
Date Cleared
1997-08-21
(37 days)
Product Code
NAE, MGQ
Regulation Number
878.4022Why did this record match?
Applicant Name (Manufacturer) :
LUDLOW TECHNICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries. Ad-Heal™ Bydrogel Dressing is indicated for: First and Second Degree Burns Partial Thickness Wounds Donor Sites Pressure Ulcers Abrasions Note: Ad-Healm is not indicated for full thickness or infected wounds or for third degree burns. This is a disposable, short term (less than 72 hours between changes) device for single patient use
Device Description
This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries. This is a disposable, short term (less than 72 hours between changes) device for single patient use
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K Number
K964401Device Name
KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
Manufacturer
LUDLOW TECHNICAL PRODUCTS
Date Cleared
1997-02-06
(94 days)
Product Code
FMT
Regulation Number
880.5130Why did this record match?
Applicant Name (Manufacturer) :
LUDLOW TECHNICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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