Percutaneous Introducer Set
by Thomas Medical Products, Inc. 2 variants
510(k) K902275
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902275 | Date26 Sep 1990 | 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- Withdrawn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
- DYB
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Percutaneous Introducer Set is a vascular access device designed for percutaneous insertion into blood vessels. It facilitates the introduction of catheters, guidewires, or other interventional tools during procedures such as embolization. Constructed as a sterile, single-use assembly, it ensures controlled access while minimizing trauma to the vessel wall. Its design aligns with Class 2 medical device standards, balancing safety and procedural efficiency in interventional radiology.
This set is supplied as a sterile, single-use device intended for use in controlled clinical environments such as catheterization labs or interventional radiology suites. It requires no special storage conditions beyond standard medical device protocols and is compatible with standard imaging modalities, including MRI, provided non-ferromagnetic materials are confirmed. The device was cleared under FDA 510(k) K902275 via the traditional review pathway, with a clearance date of September 26, 1990. No additional regulatory markings or certifications are referenced beyond this clearance.
Other devices from Thomas Medical Products, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Percutaneous Introducer Set designed for?
The Percutaneous Introducer Set is specifically engineered for percutaneous insertion into blood vessels to facilitate the introduction of catheters, guidewires, or other interventional tools during procedures like embolization. Its design minimizes vessel wall trauma while providing controlled access, making it ideal for interventional radiology settings such as catheterization labs.
Is the Percutaneous Introducer Set sterile and single-use?
Yes, the Percutaneous Introducer Set is supplied as a sterile, single-use assembly. This design ensures patient safety by preventing cross-contamination and reduces the risk of infection, aligning with best practices for medical devices used in clinical environments.
What storage conditions are required for this device?
The device does not require special storage conditions beyond standard medical device protocols. It should be stored in a clean, dry environment, protected from physical damage and contamination, following general guidelines for sterile single-use medical devices.
Can the Percutaneous Introducer Set be used with MRI imaging?
The device is compatible with standard imaging modalities, including MRI, provided that non-ferromagnetic materials are confirmed. This means users must verify the absence of ferromagnetic components in the set before MRI procedures to avoid interference or safety risks.
What regulatory clearance does this device hold?
The Percutaneous Introducer Set was cleared under the FDA 510(k) pathway with the reference number K902275, following a traditional review process. The clearance date is September 26, 1990, and it falls under the Cardiovascular advisory committee classification, categorized as a Class 2 medical device.