Model #210 Stealth Defib Pads
510(k) K904462
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904462 | Date3 Dec 1990 | 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- Withdrawn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
- LDD
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
Model #210 Stealth Defib Pads are a Class 2 cardiovascular device designed for use with low-energy defibrillators, including paddles. The device is manufactured by Cardiotronics, Inc. and is identified by product code LDD.
The Model #210 Stealth Defib Pads are supplied as a single device and received FDA 510(k) clearance on December 3, 1990, under K-number K904462. The device is regulated under product code LDD and is intended for cardiovascular applications. No information regarding sterility, single-use or reusable status, MRI safety, or storage conditions is provided in the data.
Other devices from Cardiotronics, Inc.
Questions
AI-generated answers, 28 Sep 2026
What is the Model #210 Stealth Defib Pads used for?
The Model #210 Stealth Defib Pads are designed for use with low-energy defibrillators, including paddles, for cardiovascular applications. They are a Class 2 medical device manufactured by Cardiotronics, Inc.
What is the regulatory status of the Model #210 Stealth Defib Pads?
The Model #210 Stealth Defib Pads received FDA 510(k) clearance on December 3, 1990, under K-number K904462. They are regulated under product code LDD and are classified as substantially equivalent to other devices in this category.
Is the Model #210 Stealth Defib Pads single-use or reusable?
The device data does not specify whether the Model #210 Stealth Defib Pads are single-use or reusable. No information regarding sterility or single-use status is provided in the available documentation.
What are the specifications of the Model #210 Stealth Defib Pads?
The Model #210 Stealth Defib Pads are supplied as a single device. The data does not include specific measurements, sizes, or storage conditions. The device is manufactured by Cardiotronics, Inc. and is identified by product code LDD.