FDA.reportPublic FDA data

Mach1™

Primary DI
08714729842538
Brand
Mach1™
Company
BOSTON SCIENTIFIC CORPORATION
Model
H749343581910
Device description
Guide Catheter
Published
2016-09-24
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

Product Codes#

Code, Name table
CodeName
DQYCATHETER, PERCUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729842538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729842538087147298425388714729842538

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), 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 (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00802526613876LATITUDE® NXT646064602020-04-09
08714729893431ROTAPRO™ AdvancerH74939299A02018-07-11
08714729999560ROTAPRO™H749394671250H7493946712502020-07-01
08714729999577ROTAPRO™H749394671500H7493946715002020-07-01
08714729999584ROTAPRO™H749394671750H7493946717502020-07-01
08714729999591ROTAPRO™H749394672000H7493946720002020-07-01
08714729999607ROTAPRO™H749394672150H7493946721502020-07-01
08714729999614ROTAPRO™H749394672250H7493946722502020-07-01
08714729999621ROTAPRO™H749394672380H7493946723802020-07-01
08714729999638ROTAPRO™H749394672500H7493946725002020-07-01
00191506062620RIVOS™M00553900M005539002026-06-25
08714729050650Entry KitM001503500M0015035002016-01-29
08714729082026SteeroCath-Dx™M0042028BL02016-09-24
08714729085249Electrophysiology CableM00490002016-09-24
08714729114659Greenfield™M001503000M0015030002015-09-24
08714729114666Greenfield™M001503010M0015030102015-09-24
08714729124993Greenfield™M001505010M0015050102015-09-24
08714729270249Electrophysiology CableM004901AS02016-09-24
08714729270256Electrophysiology CableM004901BS02016-09-24
08714729334996Electrophysiology CableM004921B02016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008537990079308F Base Camp System 2.0 90cmROUTE 92 MEDICALDQY2026-07-08
10801902218732ARROWTELEFLEX INCORPORATEDDQY2026-06-24
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
08718481740330Guidion ShortIMDS Operations B.V.DQY2026-06-01
08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
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