Scimed Expo Angiographic Catheter
510(k) K951720
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK951720 | Date22 Jun 1995 | 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- Withdrawn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
- DQO
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1200
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Scimed Expo Angiographic Catheter is a device designed to provide a pathway for delivering contrast in angiographic procedures. It is intended for use in cardiovascular applications to facilitate diagnostic imaging and interventions.
The device is supplied by Scimed Life Systems, Inc. and received FDA 510(k) clearance on June 22, 1995 (K951720). It is classified under product code DQO and was reviewed by the Cardiovascular advisory committee. The device is available in various sizes as specified by the manufacturer.
Other devices from Scimed Life Systems, Inc.
Questions
AI-generated answers, 24 Sep 2026
What is the Scimed Expo Angiographic Catheter used for?
The Scimed Expo Angiographic Catheter is designed to provide a pathway for delivering contrast in angiographic procedures. It is intended for use in cardiovascular applications to facilitate diagnostic imaging and interventions.
How is the Scimed Expo Angiographic Catheter supplied?
The device is supplied by Scimed Life Systems, Inc. It is available in various sizes as specified by the manufacturer to accommodate different clinical needs and procedures.
What is the regulatory status of the Scimed Expo Angiographic Catheter?
The Scimed Expo Angiographic Catheter received FDA 510(k) clearance on June 22, 1995 (K951720). It is classified under product code DQO and was reviewed by the Cardiovascular advisory committee.
Is the Scimed Expo Angiographic Catheter single-use or reusable?
The device data does not specify whether the Scimed Expo Angiographic Catheter is designed for single-use or multiple uses. Clinicians should refer to the manufacturer's instructions for use to determine the appropriate handling and disposal protocols.