Cardima Seeker and Stubbie Guidewires
510(k) K932801
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK932801 | Date1 Sep 1993 | 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- Withdrawn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
- DQX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Cardima Seeker and Stubbie Guidewires are classified as guidewires (DQX) for cardiovascular use. These devices are designed to assist in the navigation and positioning of catheters within coronary or peripheral blood vessels, facilitating interventional procedures such as angioplasty or stent placement. Their construction allows for precise control and maneuverability in complex vascular anatomies, including tortuous or calcified vessels. The Seeker and Stubbie variants provide distinct tip shapes tailored for specific clinical scenarios, enhancing procedural efficacy.
These guidewires are supplied as single-use devices, intended for sterile use in controlled clinical settings such as cardiac catheterization labs. They are regulated under the FDA’s 510(k) clearance pathway (K932801) and fall under the Cardiovascular (DQX) product code. No additional sterility or MRI safety information is specified in the regulatory data. Storage and handling must comply with standard medical device protocols to maintain integrity until use. The device’s authorization reflects substantial equivalence to a predicate product, as determined by the FDA’s review process.
Other devices from Cardima, Inc.
Questions
AI-generated answers, 20 Sep 2026
What are the primary clinical uses for the Cardima Seeker and Stubbie Guidewires in interventional procedures?
The Cardima Seeker and Stubbie Guidewires are designed to assist in navigating and positioning catheters within coronary or peripheral blood vessels. Their distinct tip shapes—Seeker for general use and Stubbie for specific scenarios—help improve maneuverability in complex vascular anatomies, such as tortuous or calcified vessels. This aids in procedures like angioplasty or stent placement by providing precise control during catheter insertion.
Are the Cardima Seeker and Stubbie Guidewires intended for reuse, or are they meant to be used only once?
These guidewires are explicitly labeled as single-use devices, meaning they are intended for sterile use in one procedure only. This classification aligns with standard medical device protocols to ensure patient safety and device integrity, particularly in controlled clinical settings like cardiac catheterization labs.
How should the Cardima Seeker and Stubbie Guidewires be stored to maintain their integrity before use?
While specific storage instructions aren’t detailed in the regulatory data, standard medical device protocols should be followed to preserve the guidewires’ sterility and functionality. This typically includes keeping them in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring the packaging remains uncompromised until immediate use.
What regulatory pathway was used to clear the Cardima Seeker and Stubbie Guidewires for use in the U.S., and what does that mean for their safety?
The guidewires were cleared through the FDA’s 510(k) pathway (K932801), specifically under the Traditional review process. This clearance indicates that the FDA determined the device is *substantially equivalent* to a predicate product already on the market, meaning it meets the same performance and safety standards as its predecessor. The Cardiovascular (DQX) product code confirms their classification as cardiovascular guidewires.