Search Results
Found 2 results
510(k) Data Aggregation
K Number
K251198Device Name
HyperVue Software
Manufacturer
SpectraWAVE, Inc.
Date Cleared
2025-07-16
(90 days)
Product Code
NQQ
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SpectraWAVE, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K243016Device Name
Starlight Imaging Catheter
Manufacturer
SpectraWAVE, Inc.
Date Cleared
2025-03-20
(174 days)
Product Code
NQQ, IYO, OGZ, ORD
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SpectraWAVE, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Starlight Imaging Catheter with Hyper Vue Imaging System is intended for imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.
The Starlight Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.
The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.
Device Description
The Starlight Imaging Catheter is a sterile, single-use, non-pyrogenic device and consists of two main assemblies: the catheter body and the internal rotating fiber optic imaging core. The catheter has an insertable length of 141 cm and a 2.5 Fr imaging window. It is a rapid exchange design with monorail tip, designed for compatibility with 0.014" (0.355mm) steerable guidewires used during coronary interventional procedures.
The Starlight Imaging Catheter connects to the HyperVue Imaging System through the HyperVue Controller (Controller), a reusable catheter connection allowing direct control of basic data acquisition. All fiber optic rotation and translational pullback is driven by the Controller and occurs inside the catheter.
Ask a Question
Page 1 of 1