Haskal Torque Device
FDA 510(k) K100425 · Elcam Medical Acal
510(k) numberK100425
Submission
- Device name
- Haskal Torque Device
- Applicant
- Elcam Medical Acal
Mp. Merom Hagalil, IL - Received
- February 16, 2010
- Decision date
- June 17, 2010
- 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 Haskal Torque Device cleared by the FDA?
Haskal Torque Device (K100425) received a 510(k) decision of Substantially Equivalent on June 17, 2010, 121 days after the submission was received.
What is the product code of K100425?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.