Nipro Vascular Innovations Americas, Inc.

FDA Device Registration & Listing · Bedford, MA, US · Registration 3015551113

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015551113
FEI Number
3015551113
Entity Name
Nipro Vascular Innovations Americas, Inc.
City/State/Country
Bedford, MA, US
Establishment Address
28 Crosby Drive, Suite 100, Bedford, MA 01730, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Nipro Vascular Innovations Americas, Inc. (Owner Number: 10025766)
Owner / Operator Contact Address
28 Crosby Drive, Suite 100, Bedford, MA 01730, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42) Makoto Intravascular Imaging System™ (TVC-MC10/TVC-MC10i) Clarispro™ HD-IVUS Imaging Catheter (TVC-E195-42)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2025-03-26
OGZ Catheter, Intravascular, Plaque Morphology Evaluation Cardiovascular Class 2 870.1200 2025-03-26
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-03-26

Official Correspondent

Nozomi Yagi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nipro Vascular Innovations Americas, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003524171 Nipro Vascular Innovations Americas, Inc. SUNNYVALE, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K251211 ABBOTT MEDICAL ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™ 2025-05-23
K251231 ABBOTT MEDICAL ViewFlex™ X ICE Catheter, Sensor Enabled™ 2025-05-20
K882805 Coopervision-Cilco CILCO VILLASENOR PACHYMETER 1988-08-12
K791040 Shimadzu Corp. SECTOR SCANNER, SDU-100, COMPUTERIZED 1979-10-04
K162372 Qt Ultrasound, LLC QT Ultrasound Breast Scanner-1 2017-06-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2016 Biosense Webster, Inc. 2
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
Z-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011 Verathon, Inc. 2
AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011 Verathon, Inc. 2
BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014 SonoSite, Inc. 2
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015551113. Last updated year: 2026. Please use registration number 3015551113 when referencing this establishment in official correspondence.
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