NHancer Rx

Primary DI
08718481740231
Brand
NHancer Rx
Company
IMDS Operations B.V.
Model
NRX1413518
Catalog number
NRX1413518
Device description
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
Published
2022-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200324000NHancer RxImds Operations B.V.2020-08-06DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08718481740231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08718481740231087184817402318718481740231

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Regulatory Flags#

DUNS number
489997508
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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08718481740347FlowGuideFG60F2026-06-01
08718481740361ShapeITSI014135SI0141352025-08-08
08718481740354Micro RxRX135RX1352023-12-19
08718481740309ReCrossRC1414025RC14140252022-09-01
08718481740262TrapITTRP9015TRP90152022-09-01
08718481740279TrapITTRP10015TRP100152022-09-01

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