FDA.reportPublic FDA data

Sublime Microcatheter, 035, 135cm, Straight

Primary DI
00812339030692
Brand
Sublime Microcatheter, 035, 135cm, Straight
Company
Surmodics, Inc.
Model
SRA-MC35-STR135
Device description
Sublime Microcatheter, 035, 135cm, Straight
Published
2023-04-14
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221886000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221886000Sublime MicrocatheterSurmodics,Inc.2022-10-14DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812339030692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812339030692008123390306928123390306920812339030692

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
Catheter Length135Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
098414659
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812339030807Pounce ™ XL ThrombectomyPTS-1011-7F1352024-11-13
00812339030760Pounce ™ LP ThrombectomyPTS-0407-7F1502024-03-19
00812339030784Pounce ™ ThrombectomyPTS-0607-7F1352023-08-16
00812339030319Pounce Venous Thrombectomy SystemVTS-0018-090102023-10-27
00812339030302Pounce™ Venous Thrombectomy SystemVTS-1018-090102022-06-22
00812339030326Pounce ™ ThrombectomyPTS-0607-7F1352024-10-18
00812339030814Pounce SheathPFS-0035-16F142026-01-26
00812339030753Pounce SheathPFS-0035-12F142023-09-21
00812339030555Sublime Microcatheter, 014, 65cm, StraightSRA-MC14-STR0652023-04-14
00812339030562Sublime Microcatheter, 014, 65cm, AngleSRA-MC14-ANG0652023-04-14
00812339030579Sublime Microcatheter, 014, 150cm, StraightSRA-MC14-STR1502023-04-14
00812339030586Sublime Microcatheter, 014, 150cm, AngleSRA-MC14-ANG1502023-04-14
00812339030593Sublime Microcatheter, 014, 200cm, StraightSRA-MC14-STR2002023-04-14
00812339030609Sublime Microcatheter, 014, 200cm, AngleSRA-MC14-ANG2002023-04-14
00812339030616Sublime Microcatheter, 018, 65cm, StraightSRA-MC18-STR0652023-04-14
00812339030623Sublime Microcatheter, 018, 65cm, AngleSRA-MC18-ANG0652023-04-14
00812339030630Sublime Microcatheter, 018, 150cm, StraightSRA-MC18-STR1502023-04-14
00812339030647Sublime Microcatheter, 018, 150cm, AngleSRA-MC18-ANG1502023-04-14
00812339030654Sublime Microcatheter, 018, 200cm, StraightSRA-MC18-STR2002023-04-14
00812339030661Sublime Microcatheter, 018, 200cm, AngleSRA-MC18-ANG2002023-04-14

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