Contura Multi-Lumen Balloon Source Applicator for Brachytherapy, Models B001-45 and B011-45
FDA 510(k) K080791 · Senorx, Inc.
510(k) numberK080791
Submission
- Device name
- Contura Multi-Lumen Balloon Source Applicator for Brachytherapy, Models B001-45 and B011-45
- Applicant
- Senorx, Inc.
Aliso Viejo, CA, US - Received
- March 20, 2008
- Decision date
- April 30, 2008
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Contura Multi-Lumen Balloon Source Applicator for Brachytherapy, Models B001-45 and B011-45 cleared by the FDA?
Contura Multi-Lumen Balloon Source Applicator for Brachytherapy, Models B001-45 and B011-45 (K080791) received a 510(k) decision of Unknown on April 30, 2008, 41 days after the submission was received.
What is the product code of K080791?
The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.