Pruitt F3 Carotid Shunt - 9F Pruitt F3 Outlying Shunt with T-port - Lemaitre Vascular, Inc.

Duns Number:184805166

Device Description: 9F Pruitt F3 Outlying Shunt with T-port

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More Product Details

Catalog Number

2012-10

Brand Name

Pruitt F3 Carotid Shunt

Version/Model Number

2012-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K051067

Product Code Details

Product Code

MJN

Product Code Name

Catheter, Intravascular Occluding, Temporary

Device Record Status

Public Device Record Key

35bc7fa1-7ea7-4b24-9246-1c04810521fa

Public Version Date

April 21, 2021

Public Version Number

4

DI Record Publish Date

June 30, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LEMAITRE VASCULAR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 453
3 A medical device with high risk that requires premarket approval 22