FDA.reportPublic FDA data

BeBack Crossing Catheter

Primary DI
04260279096463
Brand
BeBack Crossing Catheter
Company
Bentley InnoMed GmbH
Model
2.9 F, 120 cm
Catalog number
GB 603-US 014P 120L
Device description
The BeBack Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures. The BeBack Crossing Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions oft he peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The BeBack Crossing Catheter is available with outer diameters of 4 F (1.4 mm) or 2.9 F (0.96 mm), accommodate 0.018“ or 0.014“ guidewires accordingly, and both diameters have effective lengths of 80 cm or 120 cm.
Published
2023-04-24
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
PDUCatheter For Crossing Total Occlusions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDUCatheter For Crossing Total OcclusionsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211802000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211802000GoBack Crossing CatheterUpstream Peripheral Technologies, Ltd.2022-03-01PDU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017837222PreviousGS10
04260279096463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017837222072900178372227290017837222
04260279096463042602790964634260279096463

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced 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 superselective small vessel microcatheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length120Centimeter
Introducer Sheath Compatibilit2.9French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a dry, dark area away from heat and chemical fluids.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49747198499510info@bentley.global

Regulatory Flags#

DUNS number
331383450
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
04260279096456BeBack Crossing Catheter2.9 F, 80 cmGB 603-US 014P 80L2023-04-24
04260279096470BeBack Crossing Catheter4 F, 80 cmGB 600-US 018P 80L2023-04-24
04260279096487BeBack Crossing Catheter4 F, 120 cmGB 600-US 018P 120L2023-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07540299000488PowerWire 14 Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2025-12-04
00860009199705Santreva-ATK Endovascular Revascularization CatheterAngiosafe, Inc.PDU2025-12-03
00850041730158LimFlow ARCLimflow Inc.PDU2024-04-19
07540299000372PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
07540299000389PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
07540299000396PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
07540299000419PowerWire Pro Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2024-03-18
00851354004554Tigereye STAVINGER, INC.PDU2023-07-24
00850041730011LimFlow ARCLimflow Inc.PDU2023-06-26
07540299000228PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000235PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000242PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000259PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000266PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
07540299000273PowerWire Radiofrequency GuideWire KitBaylis Medical Technologies IncPDU2023-06-26
04260279096456BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
04260279096470BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
04260279096487BeBack Crossing CatheterBentley InnoMed GmbHPDU2023-04-24
00851354004493TigereyeAVINGER, INC.PDU2023-03-14
07290017837109GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
07290017837116GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
07290017837222GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
07290017837239GoBack Crossing CatheterUPSTREAM PERIPHERAL TECHNOLOGIES LTDPDU2022-10-19
00801741202438Recanalization SystemBard Peripheral Vascular, Inc.PDU2022-03-30
00801741202445Recanalization SystemBard Peripheral Vascular, Inc.PDU2022-03-30
00801741202452Recanalization SystemBard Peripheral Vascular, Inc.PDU2022-03-30
00801741201332Crosser iQBard Peripheral Vascular, Inc.PDU2021-10-04