FDA Browser
by
Innolitics
Anesthesiology
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—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular 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
BRW
Protector, Dental
1
Product Code
BSF
Absorber, Carbon-Dioxide
1
Product Code
BSJ
Mask, Gas, Anesthetic
1
Product Code
BSK
Cuff, Tracheal Tube, Inflatable
2
Product Code
BSN
Filter, Conduction, Anesthetic
2
Product Code
BSO
Catheter, Conduction, Anesthetic
2
Product Code
K
23
1242
Perifix FX Catheter; Contiplex FX Catheter
2
Cleared 510(K)
K
23
0603
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
2
Cleared 510(K)
K
19
3664
SubQKath Catheter and Needle Set
2
Cleared 510(K)
K
20
0624
Percutaneous Introducer
2
Cleared 510(K)
K
19
1470
C-CAT Anaesthesia Catheter kit
2
Cleared 510(K)
K
18
1782
Medline Reinforced Epidural Catheter
2
Cleared 510(K)
K
17
3541
EPINAUT
2
Cleared 510(K)
K
17
2777
Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
2
Cleared 510(K)
K
17
1584
B. Braun Tear-Away Introducer Needle
2
Cleared 510(K)
K
17
1193
Certa Catheter
2
Cleared 510(K)
K
16
2522
UltraCath Continuous Nerve block Catheter
2
Cleared 510(K)
K
16
1232
ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit
2
Cleared 510(K)
K
15
3297
Perifix and Contiplex Catheter
2
Cleared 510(K)
K
15
2952
E-Cath
2
Cleared 510(K)
K
15
0731
Medline Epidural Catheter
2
Cleared 510(K)
K
15
0789
SPINAUT-E, SPINAUT-I
2
Cleared 510(K)
K
14
0110
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET
2
Cleared 510(K)
K
14
3164
ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
2
Cleared 510(K)
K
13
3316
SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
2
Cleared 510(K)
K
12
2661
VITAL 5 RELEAF CATHETER
2
Cleared 510(K)
K
11
1031
PAINFUSOR CATHETER
2
Cleared 510(K)
K
11
0814
AMBIT TUNNELER
2
Cleared 510(K)
K
10
2594
IO-FLEX CATHETER
2
Cleared 510(K)
K
10
2460
AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
2
Cleared 510(K)
K
09
3920
BUSSE EPIDURAL CATHETER KIT
2
Cleared 510(K)
K
09
0884
PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.
2
Cleared 510(K)
K
08
1404
SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT
2
Cleared 510(K)
K
08
0675
PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT
2
Cleared 510(K)
K
07
2702
STRYKER ANTIMIC CATHETER
2
Cleared 510(K)
K
07
2050
PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS
2
Cleared 510(K)
K
07
0465
BUSSE EPIDURAL CATHETER
2
Cleared 510(K)
K
06
3234
ON-Q INTRODUCERS
2
Cleared 510(K)
K
06
2005
PORTEX EPIDURAL CATHETER
2
Cleared 510(K)
K
05
1401
ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
2
Cleared 510(K)
K
05
1524
LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216
2
Cleared 510(K)
K
05
0557
AMT NANOCATH
2
Cleared 510(K)
K
04
3456
MODIFICATION TO SOAKER CATHETER
2
Cleared 510(K)
K
04
2488
PERIFIX CATHETER AND CONTIPLEX CATHETER
2
Cleared 510(K)
K
03
2390
MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
2
Cleared 510(K)
K
02
3140
VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
2
Cleared 510(K)
K
02
3233
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
2
Cleared 510(K)
K
02
2019
PERIFIX CATHETER CONNECTOR
2
Cleared 510(K)
K
99
1259
TE ME NA EPIDURAL CATHETER
2
Cleared 510(K)
K
00
0886
SPIROL EPIDURAL CATHETER
2
Cleared 510(K)
K
00
1717
MICOR CONDUCTION CATHETER
2
Cleared 510(K)
K
99
3592
AXIOM MULTIPURPOSE WOUND DRAIN
2
Cleared 510(K)
K
99
1879
SPRING-WOUND EPIDURAL CATHETER
2
Cleared 510(K)
K
99
2471
SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18
2
Cleared 510(K)
K
98
1329
FETH-R-KATH
2
Cleared 510(K)
K
97
1851
INTERPLEURAL ANESTHESIA CATHETER
2
Cleared 510(K)
K
95
1927
COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)
2
Cleared 510(K)
K
95
4584
RACZ EPIDURAL CATHETER
2
Cleared 510(K)
K
95
1092
CATHETER SECUREMENT DEVICE
2
Cleared 510(K)
K
93
5927
CONCORD/PORTEX EPIDURAL CATHETERS
2
Cleared 510(K)
K
93
0539
MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY
2
Cleared 510(K)
K
93
0219
KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE
2
Cleared 510(K)
K
92
4995
4 SURE TM ANESTHESIA EXTENSION SET
2
Cleared 510(K)
K
92
2113
KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATH
2
Cleared 510(K)
K
89
7194
PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL
2
Cleared 510(K)
K
89
6712
PHARMASEAL EPIDURAL CATHETER
2
Cleared 510(K)
K
90
1129
BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER
2
Cleared 510(K)
K
89
5204
EPI-CATH(TM) EPIDURAL CATHETER
2
Cleared 510(K)
K
88
4969
BIO-MATE(TM) EPIDURAL CATHETER
2
Cleared 510(K)
K
86
3792
DURACATH, GISH MODEL NO. DVAC-XXXX
2
Cleared 510(K)
K
85
4601
SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH
2
Cleared 510(K)
K
85
0009
EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER
2
Cleared 510(K)
K
85
0505
DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER
2
Cleared 510(K)
K
85
0439
DESERET EPIDURAL CATHETER
2
Cleared 510(K)
K
84
0202
EPIDURAL CATHETER
2
Cleared 510(K)
K
83
2352
3-DAY RELEASE OF ETHYLENE OXIDE DEVICE
2
Cleared 510(K)
K
83
2232
EPINEED EPIDURAL CATHETER
2
Cleared 510(K)
K
82
3702
EPIDURAL CATHETER
2
Cleared 510(K)
K
82
2436
DNA MEDICAL DURACATH
2
Cleared 510(K)
K
80
2065
CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG
2
Cleared 510(K)
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
2
Product Code
BSR
Stylet, Tracheal Tube
1
Product Code
BSZ
Gas-Machine, Anesthesia
2
Product Code
BTB
Hook, Ether
1
Product Code
BTC
Bag, Reservoir
1
Product Code
BTK
Strap, Head, Gas Mask
1
Product Code
BTL
Ventilator, Emergency, Powered (Resuscitator)
2
Product Code
BTM
Ventilator, Emergency, Manual (Resuscitator)
2
Product Code
BTO
Tube, Tracheostomy (W/Wo Connector)
2
Product Code
BTP
Dropper, Ether
1
Product Code
BTQ
Airway, Nasopharyngeal
1
Product Code
BTR
Tube, Tracheal (W/Wo Connector)
2
Product Code
BTS
Tube, Bronchial (W/Wo Connector)
2
Product Code
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
2
Product Code
BWB
Forceps, Tube Introduction
1
Product Code
BWC
Needle, Emergency Airway
2
Product Code
BWF
Spirometer, Therapeutic (Incentive)
2
Product Code
BWL
Apparatus, Electronanesthesia
3
Product Code
BYD
Condenser, Heat And Moisture (Artificial Nose)
1
Product Code
BYE
Attachment, Breathing, Positive End Expiratory Pressure
2
Product Code
BYF
Mask, Oxygen, Low Concentration, Venturi
1
Product Code
BYG
Mask, Oxygen
1
Product Code
BYH
Drain, Tee (Water Trap)
1
Product Code
BYI
Percussor, Powered-Electric
2
Product Code
BYJ
Unit, Liquid-Oxygen, Portable
2
Product Code
BYK
Tent, Oxygen, Electrically Powered
2
Product Code
BYL
Tent, Oxygen
1
Product Code
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
1
Product Code
BYO
Bottle, Blow
1
Product Code
BYP
Mouthpiece, Breathing
1
Product Code
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
2
Product Code
BYW
Device, Rebreathing
1
Product Code
BYX
Tubing, Pressure And Accessories
1
Product Code
BZA
Connector, Airway (Extension)
1
Product Code
BZB
Catheter, Nasal, Oxygen
1
Product Code
BZD
Ventilator, Non-Continuous (Respirator)
2
Product Code
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
2
Product Code
BZO
Set, Tubing And Support, Ventilator (W Harness)
1
Product Code
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
2
Product Code
CAD
Vaporizer, Anesthesia, Non-Heated
2
Product Code
CAE
Airway, Oropharyngeal, Anesthesiology
1
Product Code
CAF
Nebulizer (Direct Patient Interface)
2
Product Code
CAG
Circulator, Breathing-Circuit
2
Product Code
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
1
Product Code
CAL
Laryngoscope, Non-Rigid
1
Product Code
CAO
Airway, Esophageal (Obturator)
2
Product Code
CAT
Cannula, Nasal, Oxygen
1
Product Code
CAW
Generator, Oxygen, Portable
2
Product Code
CAZ
Anesthesia Conduction Kit
2
Product Code
CBF
Chamber, Hyperbaric
2
Product Code
CBG
Spreader, Cuff
1
Product Code
CBH
Device, Fixation, Tracheal Tube
1
Product Code
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
2
Product Code
CBK
Ventilator, Continuous, Facility Use
2
Product Code
CBL
Absorbent, Carbon-Dioxide
1
Product Code
CBN
Apparatus, Gas-Scavenging
2
Product Code
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
2
Product Code
CBP
Valve, Non-Rebreathing
2
Product Code
MOD
Accessory To Continuous Ventilator (Respirator)
2
Product Code
CCO
Bed, Rocking, Breathing Assist
2
Product Code
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
1
Product Code
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
2
Product Code
CCW
Laryngoscope, Rigid
1
Product Code
EPE
Brush, Cleaning, Tracheal Tube
1
Product Code
FNC
Tent, Pediatric Aerosol
2
Product Code
FOG
Hood, Oxygen, Infant
1
Product Code
JAY
Support, Breathing Tube
1
Product Code
JOH
Tube Tracheostomy And Tube Cuff
2
Product Code
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
1
Product Code
KGB
Mask, Oxygen, Non-Rebreathing
1
Product Code
KHA
Mask, Scavenging
1
Product Code
LNZ
Changer, Tube, Endotracheal
2
Product Code
MIA
Needle, Spinal, Short Term
2
Product Code
MNS
Ventilator, Continuous, Non-Life-Supporting
2
Product Code
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
2
Product Code
MRN
Apparatus, Nitric Oxide Delivery
2
Product Code
MRO
Apparatus, Nitric Oxide, Backup Delivery
2
Product Code
MZT
Device, Heimlich Maneuver Assist
2
Product Code
NFB
Conserver, Oxygen
2
Product Code
NHJ
Device, Positive Pressure Breathing, Intermittent
2
Product Code
NHK
Resuscitator, Manual, Non Self-Inflating
2
Product Code
NMA
Tube, Tracheal, Reprocessed
2
Product Code
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
2
Product Code
NMR
Needle, Spinal, Short Term, Reprocessed
2
Product Code
NNH
Needle, Conduction, Anesthesia, Reprocessed
2
Product Code
NOU
Continuous, Ventilator, Home Use
2
Product Code
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
2
Product Code
NVO
Spacer, Direct Patient Interface
2
Product Code
NVP
Holding Chambers, Direct Patient Interface
2
Product Code
NXA
Tracheotomy Care Kit
2
Product Code
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
2
Product Code
OFQ
Anesthesia Kit
2
Product Code
OFT
Spinal Epidural Anesthesia Kit
2
Product Code
OFU
Spinal Anesthesia Kit
2
Product Code
OFV
Regional Anesthesia Kit
2
Product Code
OGA
Brachial Plexus Anesthesia Kit
2
Product Code
OGB
Caudal Anesthesia Kit
2
Product Code
OGC
Continuous Brachial Plexus Block Tray
2
Product Code
OGD
Custom Anesthesia Tray
2
Product Code
OGE
Epidural Anesthesia Kit
2
Product Code
OGF
Glossopharyngeal Anesthesia Kit
2
Product Code
OGG
Humidifier Nebulizer Kit
2
Product Code
OGH
Laryngoscope Kit
1
Product Code
OGI
Nasal Endotracheal Tube Holder Kit
1
Product Code
OGJ
Nerve Block Tray
2
Product Code
OGL
Oxygen Administration Kit
2
Product Code
OLF
Medevac Use Oxygen Generator
2
Product Code
ONZ
Mechanical Ventilator
2
Product Code
OQU
Airway Monitoring System
2
Product Code
PHS
Oral Airway Assist
1
Product Code
PMB
External Airway
2
Product Code
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
2
Product Code
QBY
Positive Airway Pressure System
2
Product Code
QCX
Retrograde Intubation Set
2
Product Code
OZR
Intraoral Pressure Gradient Device
2
Product Code
QFB
Isocapnic Ventilation Device
2
Product Code
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
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 August 2024 at 11:05 pm
AN
/
subpart-f—therapeutic-devices
/
BSO
/
K162522
View Source
UltraCath Continuous Nerve block Catheter
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162522
510(k) Type
Traditional
Applicant
TELEFLEX MEDICAL , INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/17/2017
Days to Decision
189 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
BRW
Protector, Dental
BSF
Absorber, Carbon-Dioxide
BSJ
Mask, Gas, Anesthetic
BSK
Cuff, Tracheal Tube, Inflatable
BSN
Filter, Conduction, Anesthetic
BSO
Catheter, Conduction, Anesthetic
K
23
1242
Perifix FX Catheter; Contiplex FX Catheter
K
23
0603
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
K
19
3664
SubQKath Catheter and Needle Set
K
20
0624
Percutaneous Introducer
K
19
1470
C-CAT Anaesthesia Catheter kit
K
18
1782
Medline Reinforced Epidural Catheter
K
17
3541
EPINAUT
K
17
2777
Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
K
17
1584
B. Braun Tear-Away Introducer Needle
K
17
1193
Certa Catheter
K
16
2522
UltraCath Continuous Nerve block Catheter
K
16
1232
ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit
K
15
3297
Perifix and Contiplex Catheter
K
15
2952
E-Cath
K
15
0731
Medline Epidural Catheter
K
15
0789
SPINAUT-E, SPINAUT-I
K
14
0110
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET
K
14
3164
ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
K
13
3316
SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
K
12
2661
VITAL 5 RELEAF CATHETER
K
11
1031
PAINFUSOR CATHETER
K
11
0814
AMBIT TUNNELER
K
10
2594
IO-FLEX CATHETER
K
10
2460
AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
K
09
3920
BUSSE EPIDURAL CATHETER KIT
K
09
0884
PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.
K
08
1404
SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER KIT
K
08
0675
PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT
K
07
2702
STRYKER ANTIMIC CATHETER
K
07
2050
PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS
K
07
0465
BUSSE EPIDURAL CATHETER
K
06
3234
ON-Q INTRODUCERS
K
06
2005
PORTEX EPIDURAL CATHETER
K
05
1401
ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
K
05
1524
LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216
K
05
0557
AMT NANOCATH
K
04
3456
MODIFICATION TO SOAKER CATHETER
K
04
2488
PERIFIX CATHETER AND CONTIPLEX CATHETER
K
03
2390
MODIFICATION TO EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K
02
3140
VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124
K
02
3233
EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
K
02
2019
PERIFIX CATHETER CONNECTOR
K
99
1259
TE ME NA EPIDURAL CATHETER
K
00
0886
SPIROL EPIDURAL CATHETER
K
00
1717
MICOR CONDUCTION CATHETER
K
99
3592
AXIOM MULTIPURPOSE WOUND DRAIN
K
99
1879
SPRING-WOUND EPIDURAL CATHETER
K
99
2471
SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18
K
98
1329
FETH-R-KATH
K
97
1851
INTERPLEURAL ANESTHESIA CATHETER
K
95
1927
COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)
K
95
4584
RACZ EPIDURAL CATHETER
K
95
1092
CATHETER SECUREMENT DEVICE
K
93
5927
CONCORD/PORTEX EPIDURAL CATHETERS
K
93
0539
MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY
K
93
0219
KENDALL CURITY 20 GAUGE CONTINUOUS EPIDUAL ANESTHE
K
92
4995
4 SURE TM ANESTHESIA EXTENSION SET
K
92
2113
KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATH
K
89
7194
PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL
K
89
6712
PHARMASEAL EPIDURAL CATHETER
K
90
1129
BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER
K
89
5204
EPI-CATH(TM) EPIDURAL CATHETER
K
88
4969
BIO-MATE(TM) EPIDURAL CATHETER
K
86
3792
DURACATH, GISH MODEL NO. DVAC-XXXX
K
85
4601
SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH
K
85
0009
EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER
K
85
0505
DESERET EPIDURAL CATHETER W/TOUGHY-BORST ADAPTER
K
85
0439
DESERET EPIDURAL CATHETER
K
84
0202
EPIDURAL CATHETER
K
83
2352
3-DAY RELEASE OF ETHYLENE OXIDE DEVICE
K
83
2232
EPINEED EPIDURAL CATHETER
K
82
3702
EPIDURAL CATHETER
K
82
2436
DNA MEDICAL DURACATH
K
80
2065
CONTINUOUS EPIDURAL ANESTHESIA TRAY/DRUG
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
BSR
Stylet, Tracheal Tube
BSZ
Gas-Machine, Anesthesia
BTB
Hook, Ether
BTC
Bag, Reservoir
BTK
Strap, Head, Gas Mask
BTL
Ventilator, Emergency, Powered (Resuscitator)
BTM
Ventilator, Emergency, Manual (Resuscitator)
BTO
Tube, Tracheostomy (W/Wo Connector)
BTP
Dropper, Ether
BTQ
Airway, Nasopharyngeal
BTR
Tube, Tracheal (W/Wo Connector)
BTS
Tube, Bronchial (W/Wo Connector)
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
BWB
Forceps, Tube Introduction
BWC
Needle, Emergency Airway
BWF
Spirometer, Therapeutic (Incentive)
BWL
Apparatus, Electronanesthesia
BYD
Condenser, Heat And Moisture (Artificial Nose)
BYE
Attachment, Breathing, Positive End Expiratory Pressure
BYF
Mask, Oxygen, Low Concentration, Venturi
BYG
Mask, Oxygen
BYH
Drain, Tee (Water Trap)
BYI
Percussor, Powered-Electric
BYJ
Unit, Liquid-Oxygen, Portable
BYK
Tent, Oxygen, Electrically Powered
BYL
Tent, Oxygen
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
BYO
Bottle, Blow
BYP
Mouthpiece, Breathing
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
BYW
Device, Rebreathing
BYX
Tubing, Pressure And Accessories
BZA
Connector, Airway (Extension)
BZB
Catheter, Nasal, Oxygen
BZD
Ventilator, Non-Continuous (Respirator)
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BZO
Set, Tubing And Support, Ventilator (W Harness)
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
CAD
Vaporizer, Anesthesia, Non-Heated
CAE
Airway, Oropharyngeal, Anesthesiology
CAF
Nebulizer (Direct Patient Interface)
CAG
Circulator, Breathing-Circuit
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
CAL
Laryngoscope, Non-Rigid
CAO
Airway, Esophageal (Obturator)
CAT
Cannula, Nasal, Oxygen
CAW
Generator, Oxygen, Portable
CAZ
Anesthesia Conduction Kit
CBF
Chamber, Hyperbaric
CBG
Spreader, Cuff
CBH
Device, Fixation, Tracheal Tube
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
CBK
Ventilator, Continuous, Facility Use
CBL
Absorbent, Carbon-Dioxide
CBN
Apparatus, Gas-Scavenging
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
CBP
Valve, Non-Rebreathing
MOD
Accessory To Continuous Ventilator (Respirator)
CCO
Bed, Rocking, Breathing Assist
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
CCW
Laryngoscope, Rigid
EPE
Brush, Cleaning, Tracheal Tube
FNC
Tent, Pediatric Aerosol
FOG
Hood, Oxygen, Infant
JAY
Support, Breathing Tube
JOH
Tube Tracheostomy And Tube Cuff
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
KGB
Mask, Oxygen, Non-Rebreathing
KHA
Mask, Scavenging
LNZ
Changer, Tube, Endotracheal
MIA
Needle, Spinal, Short Term
MNS
Ventilator, Continuous, Non-Life-Supporting
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
MRN
Apparatus, Nitric Oxide Delivery
MRO
Apparatus, Nitric Oxide, Backup Delivery
MZT
Device, Heimlich Maneuver Assist
NFB
Conserver, Oxygen
NHJ
Device, Positive Pressure Breathing, Intermittent
NHK
Resuscitator, Manual, Non Self-Inflating
NMA
Tube, Tracheal, Reprocessed
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
NMR
Needle, Spinal, Short Term, Reprocessed
NNH
Needle, Conduction, Anesthesia, Reprocessed
NOU
Continuous, Ventilator, Home Use
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
NVO
Spacer, Direct Patient Interface
NVP
Holding Chambers, Direct Patient Interface
NXA
Tracheotomy Care Kit
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
OFQ
Anesthesia Kit
OFT
Spinal Epidural Anesthesia Kit
OFU
Spinal Anesthesia Kit
OFV
Regional Anesthesia Kit
OGA
Brachial Plexus Anesthesia Kit
OGB
Caudal Anesthesia Kit
OGC
Continuous Brachial Plexus Block Tray
OGD
Custom Anesthesia Tray
OGE
Epidural Anesthesia Kit
OGF
Glossopharyngeal Anesthesia Kit
OGG
Humidifier Nebulizer Kit
OGH
Laryngoscope Kit
OGI
Nasal Endotracheal Tube Holder Kit
OGJ
Nerve Block Tray
OGL
Oxygen Administration Kit
OLF
Medevac Use Oxygen Generator
ONZ
Mechanical Ventilator
OQU
Airway Monitoring System
PHS
Oral Airway Assist
PMB
External Airway
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
QBY
Positive Airway Pressure System
QCX
Retrograde Intubation Set
OZR
Intraoral Pressure Gradient Device
QFB
Isocapnic Ventilation Device
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-f—therapeutic-devices
/
BSO
/
K162522
View Source
UltraCath Continuous Nerve block Catheter
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K162522
510(k) Type
Traditional
Applicant
TELEFLEX MEDICAL , INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/17/2017
Days to Decision
189 days
Submission Type
Summary