Torque Device
FDA 510(k) K922536 · Procedure Products, Inc.
510(k) numberK922536
Submission
- Device name
- Torque Device
- Applicant
- Procedure Products, Inc.
Vancouver, WA, US - Received
- May 28, 1992
- Decision date
- December 10, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Torque Device cleared by the FDA?
Torque Device (K922536) received a 510(k) decision of Substantially Equivalent on December 10, 1992, 196 days after the submission was received.
What is the product code of K922536?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.