FlexCath Cross™ Transseptal Solution

Basic Information

• Brand Name: FlexCath Cross™ Transseptal Solution
• Primary DI: 00763000925130
• Version / Model: 900306
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-10
• Public Version: 1
• Public Version Date: 2025-08-18
• Public Version Status: New
• Public Device Record Key: 31be595a-42ff-45ca-ad69-201e14c0d483

Device Description

NDL 900306 FLEXCATH CROSS MH 63CM EIFU

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRE	DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION	Cardiovascular	870.1310	2
DYB	Introducer, catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65073	Cardiac transseptal access electrosurgical dilator/needle	A luminal, one-piece, electrosurgical device designed to be used with a transseptal vascular guide-catheter (not included) to penetrate the interatrial septum for left-heart access during a transseptal catheterization procedure. It is typically a long, thin tube that is curved and round-nosed at the distal end for positioning against the atrial septum, and incorporates an extendable, sharp needle in its lumen able to apply radio-frequency (RF) alternating current in a monopolar configuration. It may have radiopaque markers for positioning and enable acquisition of an intracardiac electrocardiogram (ECG); a guidewire and connection cables may also be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00763000925130	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K220047	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Dilator Outer Diameter 8.5 Fr (2.85 mm)
Device Size Text, specify			Guidewire Compatibility 0.82 mm
Device Size Text, specify			Curve Angle 70°
Device Size Text, specify			Guidewire Compatibility 0.032 in
Device Size Text, specify			Overall Length 75.7 cm
Device Size Text, specify			Effective Length 67.3 cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry