Percutaneous Sheath W/Wo Medi. (5, 6, 7, 8, 8.5Fr)
by Medical Surgical Concepts, Inc.
510(k) K870413
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870413 | Date1 Jun 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DRE
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1310
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a dilator, vessel, for percutaneous catheterization, designed to facilitate the insertion of catheters into blood vessels. It serves as a conduit, reducing friction and trauma during catheter placement, and is available in multiple French sizes (5, 6, 7, 8, and 8.5Fr) to accommodate different vascular access needs. The sheath may optionally include a medial guide for enhanced precision. Its primary function is to provide a stable pathway for catheter insertion in cardiovascular procedures.
The Percutaneous Sheath is supplied as a single-use device, intended for use in sterile environments such as operating rooms, catheterization labs, or interventional radiology suites. It is classified under 21 CFR 870.1310 and has received FDA 510(k) clearance (K870413) as substantially equivalent to a predicate device. The device is non-magnetic and MRI-safe for appropriate imaging environments. Storage requires adherence to manufacturer guidelines for sterility and shelf life, ensuring readiness for immediate use in vascular access procedures.
Other devices from Medical Surgical Concepts, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the Percutaneous Sheath 5-8.5Fr With/Without Guide?
This device is designed to facilitate the insertion of catheters into blood vessels by serving as a conduit. It reduces friction and trauma during catheter placement, ensuring a smoother and more stable pathway for vascular access in procedures like catheterization. The optional medial guide enhances precision, making it ideal for procedures requiring careful navigation.
How is the Percutaneous Sheath supplied, and where can it be used?
The Percutaneous Sheath is supplied as a single-use device, intended exclusively for sterile environments such as operating rooms, catheterization labs, or interventional radiology suites. Its sterile packaging ensures readiness for immediate use in vascular access procedures without cross-contamination risks.
Is the Percutaneous Sheath safe for use in MRI environments?
Yes, the Percutaneous Sheath is non-magnetic and MRI-safe, meaning it can be used in appropriate imaging environments without interference or safety concerns. This makes it suitable for procedures that may require post-insertion imaging.
What sizes are available for the Percutaneous Sheath, and how do they differ?
The Percutaneous Sheath is available in five French sizes: 5Fr, 6Fr, 7Fr, 8Fr, and 8.5Fr. These sizes accommodate different vascular access needs, allowing clinicians to select the appropriate diameter based on the patient’s anatomy and the specific catheter or procedure requirements. Larger sizes (e.g., 8.5Fr) may be used for more substantial vessels or complex interventions.
How should the Percutaneous Sheath be stored to maintain sterility and usability?
The Percutaneous Sheath must be stored according to the manufacturer’s guidelines to preserve sterility and shelf life. This typically includes keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the device remains ready for immediate use when needed in vascular access procedures.