FDA.reportPublic FDA data

Excelsior Reach

Primary DI
07613327682458
Brand
Excelsior Reach
Company
Stryker Corporation
Model
MC17PS45165-01
Catalog number
MC17PS45165-01
Device description
2 Tip PRE-SHAPED 45 Microcatheter
Published
2026-10-29
Public version status
New
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
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261649000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261649000Excelsior Reach MicrocatheterStryker Neurovascular2026-10-09QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327682458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327682458076133276824587613327682458

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
Length0
Lumen/Inner Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry, dark place.

Contacts#

Phone, Email table
PhoneEmail
+1(855)916-3876NVCustomerService@stryker.com

Regulatory Flags#

DUNS number
042405446
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
07613327682427Excelsior ReachMC17PSJ155-01MC17PSJ155-012026-10-29
07613327682434Excelsior ReachMC17PS90155-01MC17PS90155-012026-10-29
07613327682441Excelsior ReachMC17ST155-01MC17ST155-012026-10-29
07613327682465Excelsior ReachMC17PS90165-01MC17PS90165-012026-10-29
07613327682496Excelsior ReachMC17PS45155-01MC17PS45155-012026-10-29
07613327682526Excelsior ReachMC17ST165-01MC17ST165-012026-10-29
07613327682571Excelsior ReachMC17PSJ165-01MC17PSJ165-012026-10-29
07613327694796Broadway 8BRW084128-01BRW084128-012026-10-27
07613327141771SpinePlex040622200004062220002016-09-23
07613154355563Discmonitor040729000004072900002016-09-23
07613154358335MixEvac02060200000206-020-0002018-09-24
07613154687152AutoPlex, VertaPlex06056850000605-685-0002016-12-29
07613154687169AutoPlex, VertaPlex06056870000605-687-0002016-12-29
07613252018315PCD, VertaPlex05075890000507-589-0002016-12-29
07613252039259AutoPlex, VertaPlex06076870000607-687-0002017-01-03
07613252648642VertePort X4 Manifold060541150006054115002018-09-24
07613252648659VertePort X4 Manifold060540850006054085002018-09-24
07613252648888VertePort X4 Manifold060541000006054100002018-09-24
07613252648895VertePort X4 Manifold060540800006054080002018-09-24
07613252648901VertePort X4 Manifold060541050006054105002018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0086001552777687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.DQY2026-10-29
0086001552777687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-10-29
07613327682427Excelsior ReachStryker CorporationQJP2026-10-29
07613327682427Excelsior ReachStryker CorporationDQY2026-10-29
07613327682434Excelsior ReachStryker CorporationQJP2026-10-29
07613327682434Excelsior ReachStryker CorporationDQY2026-10-29
07613327682441Excelsior ReachStryker CorporationDQY2026-10-29
07613327682441Excelsior ReachStryker CorporationQJP2026-10-29
07613327682465Excelsior ReachStryker CorporationDQY2026-10-29
07613327682465Excelsior ReachStryker CorporationQJP2026-10-29
07613327682496Excelsior ReachStryker CorporationDQY2026-10-29
07613327682496Excelsior ReachStryker CorporationQJP2026-10-29
07613327682526Excelsior ReachStryker CorporationQJP2026-10-29
07613327682526Excelsior ReachStryker CorporationDQY2026-10-29
07613327682571Excelsior ReachStryker CorporationQJP2026-10-29
07613327682571Excelsior ReachStryker CorporationDQY2026-10-29
07613327694796Broadway 8Stryker CorporationQJP2026-10-27
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
00850085183002FreeClimb 46 Catheter x125cmROUTE 92 MEDICALQJP2026-10-12
00850085183019FreeClimb 46 Catheter x143cmROUTE 92 MEDICALQJP2026-10-12
00850085183026FreeClimb 46 Catheter x125cm with Tenzing 4ROUTE 92 MEDICALQJP2026-10-12
00850085183033FreeClimb 46 Catheter x143 cm with Tenzing 4ROUTE 92 MEDICALQJP2026-10-12
00850085183040Tenzing 4 Delivery CatheterROUTE 92 MEDICALQJP2026-10-12
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-10-06
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00810068568998Next Generation 088 CatheterBALT USA LLCQJP2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01