FDA.reportPublic FDA data

SmartFlow

Primary DI
00850359007049
Brand
SmartFlow
Company
MRI INTERVENTIONS, INC.
Model
NGS-NC-08
Catalog number
NGS-NC-08
Device description
Smart Flow Neuro Ventricular Cannula, 14ga, .021 ID x 10 ft x 10mm tip (short)
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCDCannula, Ventricular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCDCannula, VentricularNeurology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102101000SURGIVISION MR COMPATIBLE VENTRICULAR CANNULASurgivision, Inc.2011-01-26HCD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850359007049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850359007049008503590070498503590070490850359007049

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length10Feet
Lumen/Inner Diameter0.021Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature40 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-900-6833info@mriinterventions.com

Regulatory Flags#

DUNS number
959181160
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
00850359007042SmartFlowNGS-NC-01NGS-NC-012016-08-12
00850359007043SmartFlowNGS-NC-02NGS-NC-022016-08-12
00850359007044SmartFlowNGS-NC-03NGS-NC-032016-08-12
00850359007045SmartFlowNGS-NC-04NGS-NC-042016-08-12
00850359007046SmartFlowNGS-NC-05NGS-NC-052016-08-12
00850359007047SmartFlowNGS-NC-06NGS-NC-062016-08-12
00850359007048SmartflowNGS-NC-07NGS-NC-072016-08-12
00850359007035SmartTipNGS-DB-01NGS-DB-012016-08-12
00850359007036SmartTipNGS-DB-45NGS-DB-452016-08-12
00850359007018ClearPointNGS-PD-02-LNGS-PD-02-L2016-08-12
00850359007019ClearPointNGS-PD-03NGS-PD-032016-08-12
00850359007020ClearPointNGS-PD-03-LNGS-PD-03-L2016-08-12
00850359007021ClearPointNGS-PD-04NGS-PD-042016-08-12
00850359007022ClearPointNGS-PD-05NGS-PD-052016-08-12
00850359007056ClearPointCP-EXT-21-01CP-EXT-21-012016-11-08
00850359007057ClearPointCP-EXT-22-01CP-EXT-22-012016-11-08
00850376007001ClearPointCP- HFF-111-01CP- HFF-111-012016-08-12
00850376007002ClearPointCP-HFF-112-01CP-HFF-112-012016-08-12
00850376007003ClearPointCP-HFF-122-01CP-HFF-122-012016-08-12
00850376007004ClearPointCP- HFF-211-01CP- HFF-211-012016-08-12

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00198506056697ELMED INCORPORATEDELMED INCORPORATEDHCD2025-01-27
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G586N6888300Novo SurgicalNOVO SURGICAL, INC.HCD2023-12-18
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00842180179356ELMEDELMED INCORPORATEDHCD2023-10-05
00842180177253ELMEDELMED INCORPORATEDHCD2023-09-14
00190776373436MillenniumAvalign Technologies, Inc.HCD2023-06-23