Syntel Silicone OTW Embolectomy Catheter - Syntel Silicone OTW Embolectomy Catheter - Lemaitre Vascular, Inc.

Duns Number:184805166

Device Description: Syntel Silicone OTW Embolectomy Catheter

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More Product Details

Catalog Number

A4E08

Brand Name

Syntel Silicone OTW Embolectomy Catheter

Version/Model Number

A4E08

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)

-

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

K970762

Product Code Details

Product Code

DXE

Product Code Name

Catheter, Embolectomy

Device Record Status

Public Device Record Key

ae59f9e8-b5fc-4d13-a848-322ff720ca84

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

June 18, 2021

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