FDA.reportPublic FDA data

Headway

Primary DI
04987350609199
Brand
Headway
Company
Microvention, Inc.
Model
MC272156S-J
Catalog number
MC272156S
Device description
Microcatheter
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K142449000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142449000Headway 27 MicrocatheterMicroVention, Inc.2015-03-26DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987350609199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987350609199049873506091994987350609199

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714)247-8000customerservice@microvention.com

Regulatory Flags#

DUNS number
003263105
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842429118788WEB Detachment ControllerWDC-2-MVI-ALWDC-22026-07-30
00842429118689MV Flow Aspiration PumpMVFLOWPMP01-USMVFLOWPMP012026-07-15
00842429118795AZUR Detachment Controller45-4001-AL45-40012025-09-01
00816777020116V-Grip Detachment ControllerVG900VG5012025-08-28
00840273201991AZUR Detachment Controller45-4001-0245-40012025-08-28
00840273202028V-Grip Detachment ControllerVG900-MDRVG5012025-08-28
00842429106464V-Grip Detachment ControllerVG900-ISVG5012025-08-28
00810170018831ERIC Retrieval DeviceER173020-USERIC1730202022-10-12
00810170018848ERIC Retrieval DeviceER174030-USERIC1740302022-10-12
00810170018862ERIC Retrieval DeviceER176044-USERIC1760442022-10-12
00842429101575Sofia EX 5F - 105cm STRISC5105ST-MVIISC5105ST2019-09-25
00842429101582Sofia EX 5F - 115cm STRISC5115ST-MVIISC5115ST2019-09-25
00812636020471Azur Detachable Helical HydroCoil45-48050545-4805052015-12-29
00812636020488Azur Detachable Helical HydroCoil45-48051045-4805102015-12-29
00812636020495Azur Detachable Helical HydroCoil45-48051545-4805152015-12-29
00812636020501Azur Detachable Helical HydroCoil45-48052045-4805202015-12-29
00810170017841Azur Detachable Helical HydroCoil45-48020245-4802022015-12-29
00810170017858Azur Detachable Helical HydroCoil45-48020445-4802042015-12-29
00810170017865Azur Detachable Helical HydroCoil45-48030245-4803022015-12-29
00810170017902Azur Detachable Helical HydroCoil45-48041045-4804102015-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902219708ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902219715ARROWTELEFLEX INCORPORATEDDQY2026-08-01
10801902220445ARROWTELEFLEX INCORPORATEDDQY2026-08-01
08718122006153Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122006160Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008188Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122008195Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122013922Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122014103Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
08718122028902Primum Guiding CatheterPendraCare International B.V.DQY2026-07-30
10841156108915TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-30
10801902196719ARROWTELEFLEX INCORPORATEDDQY2026-07-29
10841156108892TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-29
00884450419922SureCrossMerit Medical Systems, Inc.DQY2026-07-24
10841156108908TRAPLINERTELEFLEX INCORPORATEDDQY2026-07-23
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06934955914720Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914737Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914744Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914751Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914768Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914775Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914782Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914799Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914805Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914812Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914829Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20