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Innolitics
Anesthesiology
Review Panel
Cardiovascular
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Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Pathology Instrumentation and Accessories
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
CAH
Filter, Bacterial, Breathing-Circuit
2
Product Code
MAJ
Catheter, Percutaneous, Intraspinal, Short Term
2
Product Code
K
96
5251
MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM
2
Cleared 510(K)
K
94
5413
MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT
2
Cleared 510(K)
K
93
4939
TEMPORARY SCREENING LEAD/ CATHETER KIT
2
Cleared 510(K)
K
93
0218
SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES
2
Cleared 510(K)
K
91
1382
IPI ALGO-LINE CATHETER
2
Cleared 510(K)
K
89
3766
LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE
2
Cleared 510(K)
OFP
Anesthesia Breathing Circuit Kit (Adult & Pediatric)
1
Product Code
LEY
Set, Oral Administration
2
Product Code
NIH
Disinfectant, Subsystem, Water Purification
2
Product Code
NII
Disinfectant, Dialysate Delivery System
2
Product Code
FLJ
Unit, Airflow, Laminar
2
Product Code
FRT
Unit, Isolation, Surgical
2
Product Code
FYD
Apparatus, Exhaust, Surgical
2
Product Code
ORC
Air Filter Portable Apparatus
2
Product Code
QGI
Air-Handling Apparatus Accessory
1
Product Code
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 May 2025 at 11:05 pm
HO
/
subpart-f—therapeutic-devices
/
MAJ
/
K930218
View Source
SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K930218
510(k) Type
Traditional
Applicant
CONCORD/PORTEX
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/27/1993
Days to Decision
193 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Pathology Instrumentation and Accessories
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
CAH
Filter, Bacterial, Breathing-Circuit
MAJ
Catheter, Percutaneous, Intraspinal, Short Term
K
96
5251
MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM
K
94
5413
MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT
K
93
4939
TEMPORARY SCREENING LEAD/ CATHETER KIT
K
93
0218
SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES
K
91
1382
IPI ALGO-LINE CATHETER
K
89
3766
LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE
OFP
Anesthesia Breathing Circuit Kit (Adult & Pediatric)
LEY
Set, Oral Administration
NIH
Disinfectant, Subsystem, Water Purification
NII
Disinfectant, Dialysate Delivery System
FLJ
Unit, Airflow, Laminar
FRT
Unit, Isolation, Surgical
FYD
Apparatus, Exhaust, Surgical
ORC
Air Filter Portable Apparatus
QGI
Air-Handling Apparatus Accessory
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
HO
/
subpart-f—therapeutic-devices
/
MAJ
/
K930218
View Source
SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K930218
510(k) Type
Traditional
Applicant
CONCORD/PORTEX
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/27/1993
Days to Decision
193 days
Submission Type
Summary