FDA.reportPublic FDA data

CoAxia FloControl™ Catheter

Primary DI
00849111030014
Brand
CoAxia FloControl™ Catheter
Company
Zoll Circulation, Inc.
Model
1028
Catalog number
8700-000776-01
Device description
The CoAxia FloControl™ Catheter is a 7F multi-lumen device with two balloons mounted near the distal tip.
Published
2015-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJNCatheter, Intravascular Occluding, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090970000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090970000FLOCONTROL , MODEL 1028Coaxia, Inc.2009-06-12MJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849111030014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849111030014008491110300148491110300140849111030014

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4085412140udisj@zoll.com

Regulatory Flags#

DUNS number
799455241
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849111076296VitalTemp™ VitalTemp™ Universal Pad, 2PK, US8700-0011312025-12-12
10849111076293VitalTemp™ VitalTemp™ Universal Pad, 2PK, US8700-0011312025-12-12
00849111076074Thermogard HQ Surface Start-Up KitSurface Start-Up Kit8700-000935-012024-05-22
00849111076081ThermoGard XP Surface Start-Up KitSurface Start-Up Kit8700-000936-012024-05-22
00849111076128Thermogard™ Vest, S/MS/M8700-000937-012024-05-22
00849111076135Thermogard™ Vest, L/XL L/XL8700-000938-012024-05-22
00849111076098STX SURFACE COOLING S/M PAD8700-000838-012024-08-15
00849111076104STX SURFACE COOLING L/XL PAD 8700-000839-012024-08-15
00849111076111STX SURFACE COOLINGTHIGHS ONLY PAD SET8700-000840-012024-08-15
00849111075787Thermogard XP, Lang set C, RohsThermogardHQ, Lang set C601337-0012023-01-17
00849111075794Thermogard XP, Lang set C, Rohs, RefurbThermogard XP, Lang set C, Rohs, Refurb2023-01-17
00849111075800Thermogard HQTM ConsoleThermogardHQ, Lang set A8700-001030-01 2022-06-27
00849111075862Thermogard HQTM Start-Up KitTG2-500D8700-001027-012022-06-27
00849111075879Thermogard HQTM Start-Up Kit EXTG2-500D, Extended Length8700-001028-012022-06-27
00849111050029Start-Up KitCG-500D8700-0666-032015-03-31
00849111050043ICY-3, Japan, Final Packaged Kit (Applause) IC-38938700-0657-032016-10-10
00849111050050Quattro, Japan, Final Packaged Kit (Applause) IC-45932016-10-10
00849111050074Cool Line® Intravascular Heat Exchange Catheter Kit (Applause)N/A8700-0654-032015-03-31
00849111050081Start-Up Kit JapanCG-500D8700-0785-032016-10-10
00849111075008Thermogard XP®Thermogard XP, Lang set B, Rohs2015-03-31

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Primary DI, Brand, Company table
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00842429103388Balloon CatheterMicrovention, Inc.MJN2022-06-14
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