Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)
FDA 510(k) K241370 · Abbott Medical
510(k) numberK241370
Submission
- Device name
- Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)
- Applicant
- Abbott Medical
Minnetonka, MN, US - Received
- May 14, 2024
- Decision date
- June 13, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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Questions and answers
When was Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) cleared by the FDA?
Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) (K241370) received a 510(k) decision of Substantially Equivalent on June 13, 2024, 30 days after the submission was received.
What is the product code of K241370?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.