FDA.reportPublic FDA data

Sniper

Primary DI
00853359008414
Brand
Sniper
Company
Embolx, Inc.
Model
SBC0629-STR-165
Catalog number
SBC0629-STR-165
Device description
The Sniper is a dual lumen, 165cm, straight tip catheter comprised of an inner guidewire/infusion lumen and an outer, annular lumen to inflate and deflate the balloon. The guidewire/infusion port may be used to inject contrast media or therapeutic agents following removal of the guidewire. The catheter has two radiopaque markers: one marker at the distal tip and another in the center of the balloon.
Published
2022-05-18
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
MJNCatheter, Intravascular Occluding, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180904000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180904000Sniper Infusion Catheter with Balloon OcclusionEmbolx, Inc.2018-06-08MJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853359008414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853359008414008533590084148533590084140853359008414

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular infusion catheterA sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor microcatheter for access into superselective small vessels. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length165Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079084339
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853359008148Soldier® S22-SP-130S22-SP-1302026-05-20
00853359008155Soldier®S22-SP-155S22-SP-1552026-05-20
00853359008186Soldier®S27-SP-130S27-SP-1302026-05-20
00853359008193Soldier®S27-SP-155S27-SP-1552026-05-20
B323SA00900SniperSA-0090SA-00902017-02-12
00853359008001SniperSBC0629-110SBC0629-1102018-06-22
00853359008018SniperSBC0629-130SBC0629-1302018-06-22
00853359008025SniperSBC0629-150SBC0629-1502018-06-22
00853359008032SniperSBC0629-STR-150SBC0629-STR-1502018-06-22
00853359008049SniperSBC0629-STR-130SBC0629-STR-1302018-06-22
00853359008056SniperSBC0629-STR-110SBC0629-STR-1102018-06-22
00853359008063Sniper®SBC0629-KTP-110SBC0629-KTP-1102018-08-29
00853359008070Sniper®SBC0629-KTP-130SBC0629-KTP-1302018-08-29
00853359008087Sniper®SBC0629-KTP-150SBC0629-KTP-1502018-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810060550816Bridge Plus occlusion balloonPhilips Image Guided Therapy CorporationMJN2025-10-09
00850001105118Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.MJN2025-06-20
00842429117545SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117552SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117569SCEPTERMicrovention, Inc.MJN2025-04-30
00842429117583SCEPTERMicrovention, Inc.MJN2025-04-30
00842429106884Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106891Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106907Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106945Balloon CatheterMicrovention, Inc.MJN2025-04-22
10628678061054COBRA-OS®Front Line Medical Technologies Inc.MJN2024-03-22
10628678061061Syringe, 10 mLFront Line Medical Technologies Inc.MJN2024-03-22
B090LRN0590LANDMARKZIEN MEDICAL TECHNOLOGIES, INC.MJN2024-01-23
B090LRN0591LANDMARKZIEN MEDICAL TECHNOLOGIES, INC.MJN2024-01-23
10628678061009COBRA-OS™Front Line Medical Technologies Inc.MJN2023-08-25
10628678061016COBRA-OS™Front Line Medical Technologies Inc.MJN2023-08-25
10628678061023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2023-08-25
20763000293424Cadence ™ Precision Injector Thread 1 mL SyringeMicro Therapeutics, Inc.MJN2022-12-23
00850001105057Prytime Medical Devices Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00850001105064Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00842429103388Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103395Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103401Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103418Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429106563Balloon CatheterMicrovention, Inc.MJN2022-06-14
16286780610016COBRA-OS™Front Line Medical Technologies Inc.MJN2022-02-09
16286780610023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2022-02-09
16286780610009COBRA-OS™Front Line Medical Technologies Inc.MJN2022-01-28
00853892004447Terumo Aortic BalloonQXMEDICALMJN2021-09-03
00857545008011WalrusQ'APEL MEDICAL LLCMJN2021-06-29