FDA.reportPublic FDA data

Benchmark MAX System

Primary DI
00815948024663
Brand
Benchmark MAX System
Company
PENUMBRA, INC.
Model
BMX7F95-A
Device description
BMX81 95cm
Published
2022-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K221822000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221822000BENCHMARK BMX81 Access SystemPenumbra, Inc.2022-11-04QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815948024663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815948024663008159480246638159480246630815948024663

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), needle 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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Regulatory Flags#

DUNS number
191077671
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810169720042ELEMENT Vascular Access SystemELMNT17F13-A2024-12-16
00810169720059ELEMENT Vascular Access SystemELMNT17F33-A2024-12-16
00810169720066ELEMENT Vascular Access SystemELMNT17F45-A2024-12-16
00810169720073ELEMENT Vascular Access SystemELMNT17F65-A2024-12-16
00810169720080ELEMENT Vascular Access SystemELMNT17F70-A2024-12-16
00810169720097ELEMENT Vascular Access SystemELMNT17F80-A2024-12-16
00815948028029MIDWAY43MWAY115-A2024-04-02
00815948028036MIDWAY62MWAY125-A2024-04-02
00815948028180MIDWAY43MWAY125-A2024-04-02
00815948028197MIDWAY62MWAY115-A2024-04-02
00815948026216Benchmark MAX SystemBMX96100SIM125-B2023-06-27
00815948026223Benchmark MAX SystemBMX96100MSIM125-B2023-06-27
00815948026230Benchmark MAX SystemBMX96100H1125-B2023-06-27
00815948026247Benchmark MAX SystemBMX96100MH1125-B2023-06-27
00815948026254Benchmark MAX SystemBMX96100BER125-B2023-06-27
00815948026261Benchmark MAX SystemBMX96100MBER125-B2023-06-27
00815948026278Benchmark MAX SystemBMX96100SIMV125-B2023-06-27
00815948026285Benchmark MAX SystemBMX96100MSIMV125-B2023-06-27
00815948026292Benchmark MAX SystemBMX96100-B2023-06-27
00815948026308Benchmark MAX SystemBMX9690SIM125-B2023-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
00191506019563Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019587Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019600Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019624Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019648Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019662Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019686Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019709Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019723Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019747Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019761Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019785Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019808Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019822Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019846Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019860Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00191506019884Rubicon™ ControlBOSTON SCIENTIFIC CORPORATIONDQY2024-02-16
00389701012896R2P NAVICROSSTERUMO MEDICAL CORPORATIONDQY2024-01-11
00389701012902R2P NAVICROSSTERUMO MEDICAL CORPORATIONDQY2024-01-11
10801902215502ARROWTELEFLEX INCORPORATEDDQY2023-07-10
10801902215267ARROWTELEFLEX INCORPORATEDDQY2023-07-07