FLASH Ostial System

Basic Information

• Brand Name: FLASH Ostial System
• Primary DI: M917OCB4014BA0
• Version / Model: OCB4014BA
• Catalog Number: OCB4014BA
• Company Name: OSTIAL CORPORATION
• Labeler DUNS: 078708447
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 5
• Public Version Date: 2019-10-07
• Public Version Status: Update
• Public Device Record Key: 8d839694-2945-4a51-80c7-750bf7925009

Device Description

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 4.0mm x 12mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	870.1250	2
DQY	Catheter, Percutaneous	Cardiovascular	870.1250	2
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	870.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17184	Peripheral angioplasty balloon catheter, basic	A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.	No	Active
47732	Coronary angioplasty balloon catheter, basic	A flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M917OCB4014BA0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K113775	000
K120738	000
K122178	000
K122379	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Catheter Length: 135cm
Device Size Text, specify			Distal Balloon Length: 12mm
Device Size Text, specify			Distal Balloon Diameter: 4.0mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry location at room temperature (~23°C)