Device
The guiding catheter (GC) will consist of a reinforced body with a hub and strain relief at the proximal end and an intermediate and soft tip at the distal end. The distal part of...
Manufacturer
PendraCare International B.V.
PendraCare International B.V.
Model: EBU3.75
Catalog: GC-P6EB370N
DI: 08718122024218
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Description
The guiding catheter (GC) will consist of a reinforced body with a hub and strain relief at the proximal end and an intermediate and soft tip at the distal end. The distal part of the catheter features a specific tip shape. A part of the catheter body features a hydrophilic coating. The GC is developed with or without side holes. The Design Inputs and Design Outputs are gathered in attachment 1 (Design Input – Design Output Table) per SOP R&D-006 (Design Input – Design Output).
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
e6beb31f-8c3c-4675-a9f3-51c167bcb1f9
Distribution Status:
In Commercial Distribution
DUNS Number:
413008652
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
38718122024219
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
08718122024218
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08718122024218
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 17846
Name: Vascular guide-catheter, single-use
Definition:
A 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.
FDA Product Codes
DQY
Catheter, Percutaneous
Premarket Submissions
Submission Number:
K250972
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
Centimeter
Item #1 - Size - @attributes - Value:
100
Item #1 - Size Type:
Catheter Length
Item #2 - Size Text:
6F
Item #2 - Size Type:
Device Size Text, specify