Agilis HisPro Steerable Catheter With Electrodes
FDA 510(k) K200721 · Abbott (St. Jude Medical)
510(k) numberK200721
Submission
- Device name
- Agilis HisPro Steerable Catheter With Electrodes
- Applicant
- Abbott (St. Jude Medical)
Sylmar, CA, US - Received
- March 19, 2020
- Decision date
- June 3, 2020
- 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 Agilis HisPro Steerable Catheter With Electrodes cleared by the FDA?
Agilis HisPro Steerable Catheter With Electrodes (K200721) received a 510(k) decision of Substantially Equivalent on June 3, 2020, 76 days after the submission was received.
What is the product code of K200721?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.