NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
by Synaptic Medical Corporation
510(k) K233708
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK233708 | Date16 Feb 2024 | 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- Withdrawn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
- DYB
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) is a steerable introducer system designed for intracardiac procedures. It falls under the classification of an introducer catheter, intended for facilitating the placement of cardiovascular catheters within the heart, including transseptal access. The kit includes a steerable sheath, dilator, and guidewire, enabling precise navigation through cardiac anatomy.
This sterile, single-use device is intended for use in clinical settings by electrophysiologists. It is regulated under FDA 510(k) clearance (K233708) and falls under the classification name ‘Introducer, Catheter’ with a medical specialty in cardiovascular applications. The kit is supplied as a complete set for direct procedural use, with no additional preparation required beyond standard sterile technique.
Other devices from Synaptic Medical Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) used for?
The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) is specifically designed for intracardiac procedures, enabling precise navigation and placement of cardiovascular catheters within the heart. This includes facilitating transseptal access, where accurate sheath positioning is critical for procedures like ablation or diagnostic catheterization. The steerable sheath, combined with the included dilator and guidewire, allows clinicians to navigate complex cardiac anatomy with enhanced control.
Is the NaviGo 12F Steerable Introducer Kit (S12FS-01) sterile and single-use?
Yes, the NaviGo 12F Steerable Introducer Kit (S12FS-01) is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination between procedures and eliminates the need for reprocessing, which can introduce additional variables in clinical settings. The kit is pre-packaged for direct procedural use, requiring only standard sterile technique before deployment.
Who is the intended user of this introducer kit, and what clinical setting is it designed for?
The NaviGo 12F Steerable Introducer Kit (S12FS-01) is intended for use by electrophysiologists in clinical settings. It is engineered for procedures requiring intracardiac catheterization, such as transseptal punctures or complex ablations. The design prioritizes precision and ease of use in specialized cardiovascular labs or electrophysiology suites, where sterile and controlled environments are standard.
What components are included in the NaviGo 12F Steerable Introducer Kit (S12FS-01)?
The kit includes a steerable sheath, a dilator, and a guidewire, all packaged together as a complete set. These components work synergistically to facilitate the introduction and navigation of cardiovascular catheters through the heart’s anatomy. The inclusion of these tools in a single kit streamlines the procedural workflow, reducing setup time and potential errors associated with mismatched or additional components.
How is the kit supplied, and what preparation is required before use?
The kit is supplied as a complete, ready-to-use set with no additional preparation required beyond adhering to standard sterile technique protocols. This means the sheath, dilator, and guidewire are pre-packaged and sterilized, allowing clinicians to open the kit and proceed with the procedure immediately. The design ensures minimal procedural downtime while maintaining the highest standards of sterility and safety.