Heartrail III Guiding Catheter
FDA 510(k) K113335 · Terumo Corporation
510(k) numberK113335
Submission
- Device name
- Heartrail III Guiding Catheter
- Applicant
- Terumo Corporation
Shibuya-Ku, Tokyo, JP - Received
- November 14, 2011
- Decision date
- July 16, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Heartrail III Guiding Catheter cleared by the FDA?
Heartrail III Guiding Catheter (K113335) received a 510(k) decision of Substantially Equivalent on July 16, 2012, 245 days after the submission was received.
What is the product code of K113335?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.