Search Results
Found 5 results
510(k) Data Aggregation
K Number
K031600Device Name
CONDUCTION CATHETER
Manufacturer
MICOR, INC.
Date Cleared
2003-08-13
(84 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
MICOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the subject device is for the administration of local anesthetics into intra-operative sites for post-operative pain management and for regional anesthesia outside of the epidural space. Routes of administration may be intra-operative, subcutaneous or percutaneous.
The intended use of the subject device is equivalent to the predicates K003966 and K003611
Device Description
The subject device is available as a closed end with multiple holes, fenestrated area, located radially along the lateral surface at the distal end of the device.
The subject device is radiopaque and is available in 19g and 20g sizes.
Ask a Question
K Number
K003966Device Name
WUNDCATH CONDUCTION CATHETER
Manufacturer
MICOR, INC.
Date Cleared
2001-07-17
(207 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
MICOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K001717Device Name
MICOR CONDUCTION CATHETER
Manufacturer
MICOR, INC.
Date Cleared
2000-09-20
(107 days)
Product Code
BSO
Regulation Number
868.5120Why did this record match?
Applicant Name (Manufacturer) :
MICOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K001940Device Name
MICOR ANESTHESIA CONDUCTION KIT
Manufacturer
MICOR, INC.
Date Cleared
2000-08-11
(46 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Applicant Name (Manufacturer) :
MICOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K991879Device Name
SPRING-WOUND EPIDURAL CATHETER
Manufacturer
MICOR, INC.
Date Cleared
1999-10-28
(148 days)
Product Code
BSO
Regulation Number
868.5120Why did this record match?
Applicant Name (Manufacturer) :
MICOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spring-Wound Epidiral Catheter is intended for administration of local anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia. Micor recommends that the catheter be removed or replaced every 72 hours.
Device Description
This catheter exhibits the same design and performance as the cited predicates. Its external sheath (patient-contact) material is identical to that used in the Preferred Medical predicate.
Ask a Question
Page 1 of 1