FDA.reportPublic FDA data

DABRA 101 Catheter

Primary DI
00842362100031
Brand
DABRA 101 Catheter
Company
Catheter Precision, Inc.
Model
101
Device description
Percutaneous Catheter
Published
2017-10-13
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
PDUCatheter For Crossing Total Occlusions

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170349000RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc2017-05-24PDU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842362100031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842362100031008423621000318423621000310842362100031

GMDN Terms#

Term, Definition table
TermDefinition
Atherectomy laser system beam guide-catheter, peripheralA sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), to re-establish blood flow within the vessel. It typically consists of fibreoptic materials with a laser-firing distal end and may be designed for over-the-wire (OTW) or rapid exchange insertion. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
131845013
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851424007102VIVO Positioning Patches920892082026-02-03
00851424007089VIVO900290022026-02-03
00085142400710VIVO Positioning Patches920892082026-02-03
00851424007119VIVO System900290022026-02-03
00851424007140LockeT Suture Retention Devicev293012026-01-13
00851424007157LockeT Suture Retention Devicev293012026-01-13
00842362100017PharosEX-3082017-05-04
00842362100024DABRA Laser SystemRA-3082017-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540299000426PowerWire 14 Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2025-12-04
07540299000433PowerWire 14 Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2025-12-04
07540299000471PowerWire 14 Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2025-12-04
07540299000488PowerWire 14 Radiofrequency Guidewire KitBaylis Medical Technologies IncPDU2025-12-04
00860009199705Santreva-ATK Endovascular Revascularization CatheterAngiosafe, Inc.PDU2025-12-03
00845225003425Pioneer Plus CatheterPhilips Image Guided Therapy CorporationPDU2024-08-12
00850041730158LimFlow ARCInari Medical, 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
07540299000402PowerWire 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 ARCInari Medical, 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
04260279096463BeBack 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