SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
FDA 510(k) K212977 · Cordis Corporation
510(k) numberK212977
Submission
- Device name
- SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands
- Applicant
- Cordis Corporation
Miami Lakes, FL, US - Received
- September 17, 2021
- Decision date
- February 17, 2022
- 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 SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands cleared by the FDA?
SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands (K212977) received a 510(k) decision of Substantially Equivalent on February 17, 2022, 153 days after the submission was received.
What is the product code of K212977?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.