FDA.reportPublic FDA data

Starlight Imaging Catheter

Primary DI
00860008045508
Brand
Starlight Imaging Catheter
Company
Spectrawave, Inc.
Model
951
Catalog number
951
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.
Published
2024-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
NQQSystem, Imaging, Optical Coherence Tomography (Oct)
OGZCatheter, Intravascular, Plaque Morphology Evaluation
ORDOptical Coherence Tomography, Intravascular Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Radiology2
OGZCatheter, Intravascular, Plaque Morphology EvaluationCardiovascular2
ORDOptical Coherence Tomography, Intravascular CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008045508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008045508008600080455088600080455080860008045508

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular near-infrared spectroscopy imaging system catheterA fibreoptic flexible tube intended to be percutaneously introduced into the vasculature (e.g., peripheral vessels, coronary arteries) to perform near-infrared spectroscopy [NIRS] for intravascular examination, especially for detection and image-based quantification of lipid core plaques. Its proximal end connects to a parent spectroscopy system for the transmission of light signals for viewing and analysis. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
3234016480ashah@spectrawave.com

Regulatory Flags#

DUNS number
117899663
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008045539X1-FFR9912026-05-07
00860008045515HyperVue Imaging System9319312024-02-23

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