Pheripherally Inserted Venous Catheter-Y Site
510(k) K932433
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESK | NumberK932433 | Date2 May 1994 | 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- Withdrawn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
- LJS
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5970
- Advisory Committee
- General Hospital
- FDA Decision
- SESK Substantially Equivalent — Kit
Overview
AI-generated summary, 21 Sep 2026
The Peripherally Inserted Venous Catheter-Y Site is an intravascular, therapeutic catheter intended for long-term use exceeding 30 days. It is designed to provide venous access for the administration of fluids or medications.
This device is subject to FDA 510(k) authorization. Specific details regarding its sterility, single-use status, or MRI compatibility are not provided in the available documentation.
Other devices from Pharmacia Deltec, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the intended use of the Peripherally Inserted Venous Catheter-Y Site?
This device is an intravascular, therapeutic catheter designed to provide venous access for the administration of fluids or medications to a patient.
Is this catheter suitable for long-term treatment?
Yes, the device is specifically intended for long-term use, defined as a duration exceeding 30 days.
What is the regulatory status of this device?
The Peripherally Inserted Venous Catheter-Y Site is subject to FDA 510(k) authorization, which indicates it has been cleared for market distribution under the specified regulatory pathway.