PeriCross Epicardial Access Kit

Basic Information

• Brand Name: PeriCross Epicardial Access Kit
• Primary DI: 10851498007395
• Version / Model: PC-1013
• Company Name: CIRCA Scientific, Inc.
• Labeler DUNS: 963223222
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-23
• Public Version: 2
• Public Version Date: 2025-08-04
• Public Version Status: Update
• Public Device Record Key: afa229f9-9bcd-42e2-b5f8-94cad4f7bcab

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62769	Epicardial catheter introduction set	A collection of sterile, invasive, non-steerable devices intended to provide percutaneous sub-xiphoid access to enable introduction of a diagnostic catheter (not included) to the epicardial surface of the heart. It primarily includes: 1) a percutaneous introducer sleeve/tunneller with obturator, intended for initial introduction; 2) a retracting mechanism, intended to grab and separate the pericardium from the epicardial surface; 3) a needle, intended to puncture the pericardium; and 4) a haemostatic valve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10851498007395	GS1

Premarket Submissions

Submission Number	Supplement Number
K243954	000