Hyperflex Flexible Guidewires
FDA 510(k) K941711 · Linvatec Corp.
510(k) numberK941711
Submission
- Device name
- Hyperflex Flexible Guidewires
- Applicant
- Linvatec Corp.
Largo, FL, US - Received
- April 6, 1994
- Decision date
- August 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
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Questions and answers
When was Hyperflex Flexible Guidewires cleared by the FDA?
Hyperflex Flexible Guidewires (K941711) received a 510(k) decision of Substantially Equivalent on August 26, 1994, 142 days after the submission was received.
What is the product code of K941711?
The FDA product code is LXH – Orthopedic Manual Surgical Instrument, a Class I (low risk) device regulated under 21 CFR 888.4540.