Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
FDA 510(k) K240997 · Abbott Medical
510(k) numberK240997
Submission
- Device name
- Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
- Applicant
- Abbott Medical
Santa Clara, CA, US - Received
- April 11, 2024
- Decision date
- November 6, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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Questions and answers
When was Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire cleared by the FDA?
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (K240997) received a 510(k) decision of Substantially Equivalent on November 6, 2024, 209 days after the submission was received.
What is the product code of K240997?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.