FDA.reportPublic FDA data

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter

Primary DI
00850044399062
Brand
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter
Company
NORTH EAST SCIENTIFIC INC
Model
R-410-154
Catalog number
R-410-154
Device description
The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES)
Published
2025-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QTFReprocessed Atherectomy Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTFReprocessed Atherectomy CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220171000NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy CatheterNortheast Scientific, Inc.2022-07-01QTF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B227NRP1300PreviousHIBCC0
00850044399062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044399062008500443990628500443990620850044399062

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Working Length150Centimeter
Introducer Sheath Compatibilit4French
Lumen/Inner Diameter0.014Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
203-756-2111sales@nescientific.com

Regulatory Flags#

DUNS number
608625823
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B227RS014R1NES Reprocessed .014 Stryker CatheterR-S014RR-S014R2024-08-15
00850044399000NES Reprocessed Varicose Vein RF CatheterCF7-7-60R-CF7-7-602025-05-21
00850044399017NES Reprocessed Varicose Vein RF CatheterCF7-7-100R-CF7-7-1002025-05-21
00850044399024NES Reprocessed Varicose Vein RF CatheterCF7-3-60R-CF7-3-602025-05-21
00850044399031NES Reprocessed RF Stylet (RFS)R-RFS2-6-12R-RFS2-6-122025-05-21
00850044399048EsoSure1000011000012025-05-21
00850044399055NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy CatheterR-410-152R-410-1522025-05-21
00850044399079NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy CatheterR-420-006R-420-0062025-05-21
00850044399086NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy CatheterR-420-159R-420-1592025-05-21
00850044399093NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy CatheterR-417-152R-417-1522025-05-21
00850044399109NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy CatheterR-417-156R-417-1562025-05-21
00850044399116NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy CatheterR-414-151R-414-1512025-05-21
00850044399123NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy CatheterR-414-159R-414-1592025-05-21
00850044399130NES Reprocessed Visions PV .035 Digital IVUS CatheterR-88901R-889012025-05-21
00850044399147NES Reprocessed Visions PV .014P RX Digital IVUS CatheterR-014RR-014R2025-05-21
00850044399154NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterR-85900P2025-05-21
00850044399161NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short TipR-85900PST2025-05-21
00850044399208NES Reprocessed .014 Stryker CatheterR-S014RR-S014R2025-05-21
00850044399215NES Reprocessed Eagle Eye Platinum Long Tip StrykerR-S85900PR-S85900P2025-05-21
00850044399222NES Reprocessed Eagle Eye Platinum Short Tip StrykerR-S85900PSTR-S85900PST2025-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044399055NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2025-05-21
00850044399079NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2025-05-21
00850044399086NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2025-05-21
00850044399093NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2025-05-21
00850044399109NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2025-05-21
00850044399116NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2025-05-21
00850044399123NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2025-05-21
B227NRP1301NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2023-09-15
B227NRP1302NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2023-09-15
B227NRP1303NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2023-09-15
B227NRP3681NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2023-09-15
B227NRP3682NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2023-09-15
B227NRP3683NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2023-09-15
B227NRP1300NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2023-07-12
B227NRP3680NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2023-07-12
NRP130NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2022-12-08
NRP368NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy CatheterNORTH EAST SCIENTIFIC INCQTF2022-08-22