Mechanical Guidewire
FDA 510(k) K221351 · Baylis Medical Company, Inc.
510(k) numberK221351
Submission
- Device name
- Mechanical Guidewire
- Applicant
- Baylis Medical Company, Inc.
Mississauga, CA - Received
- May 10, 2022
- Decision date
- December 19, 2022
- 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 Mechanical Guidewire cleared by the FDA?
Mechanical Guidewire (K221351) received a 510(k) decision of Substantially Equivalent on December 19, 2022, 223 days after the submission was received.
What is the product code of K221351?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.