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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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 (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
489997508
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08718481740330Guidion ShortGS60F2026-06-01
08718481740347FlowGuideFG60F2026-06-01
08718481740361ShapeITSI014135SI0141352025-08-08
08718481740354Micro RxRX135RX1352023-12-19
08718481740262TrapITTRP9015TRP90152022-09-01
08718481740279TrapITTRP10015TRP100152022-09-01
08718481740309ReCrossRC1414025RC14140252022-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08718481740330Guidion ShortIMDS Operations B.V.DQY2026-06-01
08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
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