Catheter, Polyurethane, W/Stylet
by Abbott Laboratories 510(k)
Active
510(k) K770868
Overview
This device is a catheter, intravascular, diagnostic, designed for insertion into blood vessels to facilitate the passage of a stylet or guidewire. Constructed from polyurethane, it is intended for use in cardiovascular procedures to assist in the placement of other intravascular devices or for diagnostic angiography. Its structure allows for flexibility and durability within vascular environments, ensuring safe and effective navigation through blood vessels.
The catheter is supplied as a single-use medical device, intended for sterile use in clinical settings. It is classified under product code DQO and has received FDA 510(k) clearance (K770868) as substantially equivalent to a predicate device. No additional regulatory markings regarding MRI safety or reusable status are specified. Storage and handling should adhere to standard aseptic protocols for intravascular diagnostic catheters.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770868 | Date27 Jun 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
Other devices from Abbott Laboratories
Questions
What is the primary use of this polyurethane catheter with stylet?
This catheter is designed for intravascular diagnostic procedures, specifically to assist in the placement of other intravascular devices or for performing diagnostic angiography. Its polyurethane construction provides flexibility and durability, allowing safe navigation through blood vessels during cardiovascular interventions.
Is this catheter intended for single-use or reusable applications?
This catheter is explicitly supplied as a single-use medical device. It is intended for sterile use in clinical settings only once, adhering to standard aseptic protocols to ensure patient safety and prevent contamination.
What regulatory clearance does this catheter hold, and what does it mean?
This catheter holds FDA 510(k) clearance under the reference number K770868, indicating it is deemed substantially equivalent to a predicate device already on the market. This clearance confirms that the device meets regulatory standards for safety and effectiveness as determined by the FDA.
How should this catheter be stored and handled?
Storage and handling of this catheter must follow standard aseptic protocols for intravascular diagnostic catheters. This includes maintaining sterility, protecting from physical damage, and ensuring it is stored in a clean, dry environment until use to preserve its integrity and functionality.
What product code category does this catheter fall under?
This catheter is classified under product code DQO, which categorizes it within the FDA’s regulatory framework for intravascular diagnostic catheters. This classification helps streamline its review and approval process.