Hunter-Sessions Vena-Cava Occluder
by Concept, Inc. PMA
Active
PMA P770005
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP770005 | Date19 Dec 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Generic Name
- OCCLUDER, BALLOON, VENA-CAVA
- PMA Number
- FDA Product Code
- LWT
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Hunter-Sessions Vena-Cava Occluder is a balloon-type occluder designed for use in the vena cava. It is classified as a Class III medical device under the generic name Occluder, Balloon, Vena-Cava.
This device received FDA Premarket Approval (PMA) under number P770005, with a decision date of December 19, 1977. It is manufactured by Concept, Inc. in Clearwater, Florida, and is intended for cardiovascular applications as indicated by its advisory committee classification.
Other devices from Concept, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the device type of the Hunter-Sessions Vena-Cava Occluder?
The device type is an occluder, specifically a balloon-type device for the vena cava, as defined by its generic name: Occluder, Balloon, Vena-Cava.
What regulatory authorization does the Hunter-Sessions Vena-Cava Occluder have?
The device has FDA Premarket Approval (PMA) under application number P770005, which was approved on December 19, 1977.
Who manufactures the Hunter-Sessions Vena-Cava Occluder and where are they located?
The device is manufactured by Concept, Inc., located at 12707 U.S. 19 S., Clearwater, FL 33546.