Asahi Angiographic Catheter
FDA 510(k) K051561 · Asahi Intecc Co., Ltd.
510(k) numberK051561
Submission
- Device name
- Asahi Angiographic Catheter
- Applicant
- Asahi Intecc Co., Ltd.
Newport Beach, CA, US - Received
- June 13, 2005
- Decision date
- November 2, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Asahi Angiographic Catheter cleared by the FDA?
Asahi Angiographic Catheter (K051561) received a 510(k) decision of Substantially Equivalent on November 2, 2005, 142 days after the submission was received.
What is the product code of K051561?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.