FDA.reportPublic FDA data

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter

Primary DI
NRP014
Brand
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
Company
NORTH EAST SCIENTIFIC INC
Model
R-014R
Catalog number
R-014R
Device description
The device is the Philips Vision PV .014P RX Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES).
Published
2020-08-20
Public version status
Update
Distribution status
Not 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
OBJCatheter, Ultrasound, Intravascular
OWQReprocessed Intravascular Ultrasound Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBJCatheter, Ultrasound, IntravascularCardiovascular2
OWQReprocessed Intravascular Ultrasound CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200195000NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNortheast Scientific, Inc.2020-06-22OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
NRP014PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular ultrasound imaging catheter, reprocessedA flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes a single or an array of transducer element(s). This is a previously used single-use device that has been processed for an additional single-use patient application.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge3.5French
Catheter Working Length150Centimeter
Lumen/Inner Diameter0.014Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
203-756-2111info@smarthealth-care.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
00850044399062NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy CatheterR-410-154R-410-1542025-05-21
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

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Primary DI, Brand, Company table
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10841898137266N/AINNOVATIVE HEALTH LLCOWQ2026-05-07
16975345061102Disposable Intracardiac Echocardiography CatheterJiangsu Tingsn Technology Co., Ltd.OBJ2026-01-31
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00845225003364Eagle Eye Platinum RX Digital IVUS CatheterPhilips Image Guided Therapy CorporationOBJ2025-09-24
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10197344149537MEDLINEMEDLINE INDUSTRIES, INC.OWQ2025-09-08
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