FDA.reportPublic FDA data

Boosting Catheter

Primary DI
00853892004058
Brand
Boosting Catheter
Company
QXMEDICAL
Model
BC52-150
Catalog number
BC52-150
Device description
"Support Catheter, .052"" ID x 150cm"
Published
2018-07-11
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
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160561000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160561000Boosting CatheterQxmedical, LLC2016-11-02DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853892004058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853892004058008538920040588538920040580853892004058

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length150Centimeter
Lumen/Inner Diameter0.052Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-842-2050admin@qxmedical.com

Regulatory Flags#

DUNS number
022672652
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853892004447Terumo Aortic Balloon120cm28-W1-50-08-120G2021-09-03
00853892004119VitaleVITB08VITB082019-05-24
00853892004126VitaleVITB10VITB102019-05-24
00853892004003Q50 PlusQ50-65PQ50-65P2016-06-08
00853892004010Q50 PlusQ50-100PQ50-100P2016-06-08
00853892004065ResQResQ-11ResQ-112017-02-27
00853892004072Q50XQ50-65-XQ50-65-X2019-01-23
00853892004089Q50XQ50-100-XQ50-100-X2019-01-23
00853892004140Camaro Support CatheterCAM-035-180CAM-035-1802020-07-14
00853892004157Camaro Support CatheterCAM-035-150CAM-035-1502020-07-14
00853892004164Camaro Support CatheterCAM-035-135CAM-035-1352020-07-14
00853892004171Camaro Support CatheterCAM-035-090CAM-035-0902020-07-14
00853892004188Camaro Support CatheterCAM-035-065CAM-035-0652020-07-14
00853892004195Camaro Support CatheterCAM-018-180CAM-018-1802020-07-14
00853892004201Camaro Support CatheterCAM-018-150CAM-018-1502020-07-14
00853892004218Camaro Support CatheterCAM-018-135CAM-018-1352020-07-14
00853892004225Camaro Support CatheterCAM-018-090CAM-018-0902020-07-14
00853892004232Camaro Support CatheterCAM-018-065CAM-018-0652020-07-14
00853892004249Camaro Support CatheterCAM-014-180CAM-014-1802020-07-14
00853892004256Camaro Support CatheterCAM-014-150CAM-014-1502020-07-14

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Primary DI, Brand, Company table
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