Isolation Sleeve Model 348-01
by Intermedics, Inc. 510(k)
Active
510(k) K790100
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790100 | Date24 Jan 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- DXY
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Isolation Sleeve Model 348-01 is a sterile, single-use barrier device designed to maintain isolation and sterility during the handling and implantation of implantable pacemaker pulse-generators. It is classified as a Class III medical device under FDA regulations, indicating its high-risk nature and critical role in procedural sterility.
This device is intended for use in sterile operating environments, such as cardiac catheterization or surgical suites, where it provides a protective barrier around the pulse-generator during preparation and implantation. Supplied as a sterile package, it adheres to FDA 510(k) clearance (K790100) and is regulated under product code DXY (Implantable Pacemaker Pulse-Generator). No additional sterilization or reuse is permitted.
Other devices from Intermedics, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Isolation Sleeve Model 348-01 in a clinical setting?
The Isolation Sleeve Model 348-01 is designed as a sterile, single-use barrier to maintain isolation and sterility during the handling and implantation of implantable pacemaker pulse-generators. It acts as a protective shield in sterile environments like cardiac catheterization or surgical suites to prevent contamination of the pulse-generator before and during the procedure.
Is the Isolation Sleeve Model 348-01 intended for reuse, or is it meant for single-use only?
The Isolation Sleeve Model 348-01 is explicitly labeled as a single-use device. The manufacturer prohibits any form of reuse or additional sterilization, ensuring that each sleeve remains sterile and uncontaminated for one-time procedural use only.
How is the Isolation Sleeve Model 348-01 supplied, and what does this mean for its handling?
The Isolation Sleeve Model 348-01 is supplied as a sterile package, meaning it is pre-sterilized and ready for immediate use in sterile environments. This eliminates the need for further sterilization by the user, ensuring procedural sterility as long as the package remains unopened and intact.
What regulatory pathway was followed for the FDA clearance of the Isolation Sleeve Model 348-01?
The Isolation Sleeve Model 348-01 underwent a traditional 510(k) clearance process through the FDA, with a decision date of January 24, 1979. It was reviewed by the Cardiovascular (CV) Advisory Committee and classified as a Class III device, reflecting its high-risk nature and critical role in maintaining sterility during pacemaker implantation procedures.
Are there different sizes or models of the Isolation Sleeve available, or is this a one-size-fits-all device?
The provided data only references the Isolation Sleeve Model 348-01, which suggests it is a specific, standardized design for pacemaker pulse-generators. There is no mention of alternative sizes or models in the available information, so it appears to be a single, unified product for this application.