FDA.reportPublic FDA data

Boosting Catheter

Primary DI
00853892004034
Brand
Boosting Catheter
Company
QXMEDICAL
Model
BC63-150
Catalog number
BC63-150
Device description
Support Catheter, .063" ID x 150cm
Published
2017-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00853892004034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853892004034008538920040348538920040340853892004034

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA 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), needle 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 can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Lumen/Inner Diameter0

Contacts#

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

Regulatory Flags#

DUNS number
022672652
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00853892004263Camaro Support CatheterCAM-014-135CAM-014-1352020-07-14
00853892004270Camaro Support CatheterCAM-014-090CAM-014-0902020-07-14
00853892004287Camaro Support CatheterCAM-014-065CAM-014-0652020-07-14
00853892004027Boosting CatheterBC57-150BC57-1502016-11-23
00853892004041Boosting CatheterBC72-150BC72-1502018-07-11
00853892004058Boosting CatheterBC52-150BC52-1502018-07-11
00853892004447Terumo Aortic Balloon120cm28-W1-50-08-120G2021-09-03
00853892004119VitaleVITB08VITB082019-05-24

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Primary DI, Brand, Company table
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08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
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