ProCatid System kit Finished Good - The ProCatid Embolic Protection System is a - GARDIA MEDICAL LTD

Duns Number:531908965

Device Description: The ProCatid Embolic Protection System is a temporary embolic protection system, filtering The ProCatid Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is provided sterile and for single use. The system is a rapid exchange, pre-loaded filter that can be used with commercially available 0.014" guide wires. After the guidewire of choice is properly located in the target vessel, the filter is delivered, locked and deployed on the wire, at any location according to physician's discretion. The locking mechanism is remotely activated, allowing the stand-alone filter unit to be positioned in any location along the vessel without compromising wire performance and support. At the end of the procedure, the filter is retrieved along with the wire.SYSTEM COMPONENTS:1 Delivery Catheter DI 7290015512022 1 Retrieval Catheter DI 7290015512039

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More Product Details

Catalog Number

P2-9-0705-S

Brand Name

ProCatid System kit Finished Good

Version/Model Number

P2-9-0705-S

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

K143570,K143570

Product Code Details

Product Code

NTE

Product Code Name

Temporary Carotid Catheter For Embolic Capture

Device Record Status

Public Device Record Key

1539c72e-6586-4d99-a5db-76d3f0943b0a

Public Version Date

July 20, 2020

Public Version Number

5

DI Record Publish Date

February 12, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GARDIA MEDICAL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6