Spinnaker
510(k) K965189
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK965189 | Date24 Mar 1997 | 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- Withdrawn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
- KRA
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1210
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Spinnaker is a continuous flush catheter indicated for facilitating access through distal, tortuous vasculature. It may be used for the controlled, regional infusion of diagnostic agents, such as contrast media and Target Therapeutics' Berenstein Liquid Coil -10 in the peripheral and neuro vasculature.
The device is not intended for use in the coronary vasculature. It is a Class II device with FDA 510(k) clearance (K965189) and product code KRA. The Spinnaker is supplied by Target Therapeutics and is regulated under regulation number 870.1210.
Other devices from Target Therapeutics
Questions
AI-generated answers, 26 Sep 2026
What is the Spinnaker catheter used for?
The Spinnaker catheter is used for facilitating access through distal, tortuous vasculature and for the controlled, regional infusion of diagnostic agents, such as contrast media.
Is the Spinnaker catheter intended for use in the coronary vasculature?
No, the Spinnaker catheter is not intended for use in the coronary vasculature.
What type of device is the Spinnaker?
The Spinnaker is a Class II device with FDA 510(k) clearance.