Depuy (Nitino) Guide Wire
FDA 510(k) K914693 · Depuy, Inc.
510(k) numberK914693
Submission
- Device name
- Depuy (Nitino) Guide Wire
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- October 18, 1991
- Decision date
- December 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JDQ – Cerclage, Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3010
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Depuy (Nitino) Guide Wire cleared by the FDA?
Depuy (Nitino) Guide Wire (K914693) received a 510(k) decision of Substantially Equivalent on December 9, 1991, 52 days after the submission was received.
What is the product code of K914693?
The FDA product code is JDQ – Cerclage, Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3010.