RF ENHANCR® II

Basic Information

• Brand Name: RF ENHANCR® II
• Primary DI: 00643169147980
• Version / Model: 39746534
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-23
• Public Version: 5
• Public Version Date: 2022-07-26
• Public Version Status: Update
• Public Device Record Key: 3f3718ba-185a-45ba-b8c8-092eb4061f2a
• Distribution End Date: 2021-01-19

Device Description

CATH 39746534 RF ENHANCR II W/O CE

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
LPB	Cardiac ablation percutaneous catheter	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61785	Cardiac radio-frequency ablation system catheter	A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169147980	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P930029	021
P930029	055

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Catheter usable length 90 cm
Device Size Text, specify			Catheter distal electrode size 4.0 mm
Device Size Text, specify			Catheter deflectable tip length 65 mm
Device Size Text, specify			Catheter electrode size 7 Fr
Device Size Text, specify			Catheter size 7 Fr

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: – 95 Percent (%) Relative Humidity