Imager II Angiographic Catheter
FDA 510(k) K121694 · Boston Scientific Corp
510(k) numberK121694
Submission
- Device name
- Imager II Angiographic Catheter
- Applicant
- Boston Scientific Corp
Maple Grove, MN, US - Received
- June 7, 2012
- Decision date
- September 14, 2012
- 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 Imager II Angiographic Catheter cleared by the FDA?
Imager II Angiographic Catheter (K121694) received a 510(k) decision of Substantially Equivalent on September 14, 2012, 99 days after the submission was received.
What is the product code of K121694?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.