510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Nipro Vascular Innovations Americas, Inc.

Sunnyvale, CA, US

Nipro Vascular Innovations Americas, Inc. appears in FDA device records in Sunnyvale, CA. FDA records list 11 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
1
Registered establishments
2

FDA records under these names

1 name

FDA records resolved to Nipro Vascular Innovations Americas, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Infraredx, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 11 510(k) clearances for Nipro Vascular Innovations Americas, Inc. between 2006 and 2025. The busiest year on record is 2013, with 2. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Nipro Vascular Innovations Americas, Inc., by decision year
YearClearances
20061
20081
20101
20132
20142
20171
20191
20211
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K241576Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )OGZSubstantially Equivalent
K213303Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42IYOSubstantially Equivalent
K183599Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging CatheterOGZSubstantially Equivalent
K163345TVC Imaging System, TVC CatheterOGZSubstantially Equivalent
K141682TVC IMAGING SYSTEM, TVC INSIGHT CATHETEROGZSubstantially Equivalent
K133897TVC IMAGING SYSTEM, TVC INSIGHT CATHETEROGZSubstantially Equivalent
K130719TVC IMAGING SYSTEM, TVC INSIGHT CATHETEROGZSubstantially Equivalent
K123108TVC IMAGING SYSTEM MODEL NIRS-MC7-70OGZSubstantially Equivalent
K093993LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70OGZSubstantially Equivalent
K072932INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5OGZSubstantially Equivalent
K052908INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5DQOSubstantially Equivalent

Registered establishments

FDA registered establishments for Nipro Vascular Innovations Americas, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30035241713003524171Nipro Vascular Innovations Americas, Inc.870 Hermosa Dr, SUNNYVALE, CA 94085 US2026
30155511133015551113Nipro Vascular Innovations Americas, Inc.28 Crosby Drive, Suite 100, Bedford, MA 01730 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0940-2017TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal viewsNear-infrared spectroscopic image (Chemogram) generated by the TVC Imaging System TVC-MC9 in some cases demonstrated an unusual appearance in that the yellow in the image (indicating the presence of lipid core plaques) was horizontally-orientedClass IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain