NHancer Rx - The NHancer™Rx is a dual lumen catheter intended - IMDS Operations B.V.

Duns Number:489997508

Device Description: The NHancer™Rx is a dual lumen catheter intended to use in the coronary and/or peripheral The NHancer™Rx is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The NHancer™Rx is a 0.014” Rapid Exchange (Rx) guide wire support catheter. The NHancer™Rx has an over the wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal end. The NHancer™Rx has an effective length of 135 cm and is compatible with 0.014”/0.36mm or smaller guide wires. The NHancer™Rx has two depth markings located at 95 cm and 105 cm from the distal tip. The NHancer™Rx has a radiopaque marker identifying the distal end of the catheter and a second radiopaque marker located 8 mm from the distal tip identifies the distal end of the OTW lumen.To reduce friction in the guide catheter and vasculature, the distal 15 cm of the shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the lumen, the entire lumens of the NHancer Rx are coated with MDX (silicone) coating.To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet (9) is placed in the OTW lumen

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More Product Details

Catalog Number

NRX1413518

Brand Name

NHancer Rx

Version/Model Number

NRX1413518

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

K200324

Product Code Details

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Device Record Status

Public Device Record Key

e7d82ae7-23fc-47bc-ab2a-3fb234db6a80

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