ReCross - The ReCross is a dual lumen catheter intended to - IMDS Operations B.V.

Duns Number:489997508

Device Description: The ReCross is a dual lumen catheter intended to use in the coronary and/or peripheral vas The ReCross is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The ReCross is a 0.014” Over The Wire (OTW) guide wire support catheter. The ReCross has two over the wire OTW lumens that runs the length of the catheter. The ReCross has two depth markings located at 95 cm and 105 cm from the distal tip. The ReCross has a radiopaque marker identifying the distal end of the catheter, a second radiopaque marker in the stylet lumen located 8 mm from the distal tip identifies the distal end of the OTW lumen and a third radiopaque marker in the tip lumen located at 12 mm from the distal tip indentifying the side port.To reduce friction in the guide catheter and vasculature, the distal shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the lumen, the entire lumens of the ReCross are coated with MDX (silicone) coating.To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet is placed in the stylet lumen

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More Product Details

Catalog Number

RC1414025

Brand Name

ReCross

Version/Model Number

RC1414025

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

K210431

Product Code Details

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Device Record Status

Public Device Record Key

279532ff-506d-44a8-b9e2-71f6a68c37ee

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMDS OPERATIONS B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4