Introducer, Percutaneous
by Med Fusion Systems, Inc. 510(k)
Active
510(k) K870907
Overview
The Introducer, Percutaneous is a medical device designed to provide percutaneous access to the vascular system of a patient. It functions to permit the introduction and positioning of various minimally invasive delivery devices, such as embolization coils, within the patient's vasculature.
This device is used in interventional procedures to facilitate vascular access. It is identified under FDA 510(k) clearance K870907 and is categorized under product code DYB.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870907 | Date9 Apr 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DYB
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Med Fusion Systems, Inc.
Questions
What is the primary function of the Percutaneous Introducer?
This device is designed to provide percutaneous access to a patient's vascular system. It serves as a conduit to allow for the introduction and precise positioning of various minimally invasive delivery devices, such as embolization coils, within the vasculature during interventional procedures.
What is the regulatory status of this introducer?
The device is cleared for use under FDA 510(k) number K870907. It was determined to be substantially equivalent to existing devices by the Cardiovascular advisory committee following a traditional submission process.
How is this device categorized for regulatory purposes?
The device is classified under product code DYB, which relates to its function as a percutaneous introducer used within the cardiovascular field. This categorization is used by the FDA to track the device type and its associated regulatory requirements.