Rubicon Control Support Catheter (H749394323506A1)
FDA 510(k) K223633 · Boston Scientific Corporation
510(k) numberK223633
Submission
- Device name
- Rubicon Control Support Catheter (H749394323506A1)
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- December 5, 2022
- Decision date
- August 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Rubicon Control Support Catheter (H749394323506A1) cleared by the FDA?
Rubicon Control Support Catheter (H749394323506A1) (K223633) received a 510(k) decision of Substantially Equivalent on August 8, 2023, 246 days after the submission was received.
What is the product code of K223633?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.