Amulet Steerable Delivery Sheath
FDA 510(k) K250426 · Abbott Medical
510(k) numberK250426
Submission
- Device name
- Amulet Steerable Delivery Sheath
- Applicant
- Abbott Medical
St. Paul, MN, US - Received
- February 14, 2025
- Decision date
- April 25, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Amulet Steerable Delivery Sheath cleared by the FDA?
Amulet Steerable Delivery Sheath (K250426) received a 510(k) decision of Substantially Equivalent on April 25, 2025, 70 days after the submission was received.
What is the product code of K250426?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.