Catheter, Pacing/Monitoring
510(k) K772059
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK772059 | Date15 Nov 1977 | 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- Withdrawn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
- DYG
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1240
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Catheter, Pacing/Monitoring is a medical device designed for pacing and monitoring functions. It is classified under the product code DYG and is intended for cardiovascular applications.
This device is manufactured by Electro-Catheter Corp. and received FDA 510(k) clearance on November 15, 1977, with the K number K772059. The device is classified as Class II and is regulated under the regulation number 870.1240.
Other devices from Electro-Catheter Corp.
Questions
AI-generated answers, 27 Sep 2026
What is the Catheter Pacing/Monitoring used for?
The Catheter Pacing/Monitoring is designed for pacing and monitoring functions in cardiovascular applications. It is a Class II medical device that helps clinicians monitor and pace cardiac activity during procedures.
Is this catheter single-use or reusable?
The device data does not specify whether this catheter is single-use or reusable. Clinicians should consult the manufacturer's instructions for use to determine the appropriate handling and disposal procedures for this specific device.
What regulatory approvals does this catheter have?
This catheter received FDA 510(k) clearance on November 15, 1977, with K number K772059. It is classified as Class II under regulation number 870.1240 and is regulated by the Cardiovascular advisory committee.
What sizes and models of this catheter are available?
The device data does not specify available sizes or models for this catheter. Clinicians should contact Electro-Catheter Corp. directly or consult the product catalog for specific size options and model variations that may be available.