ProTrack Pigtail Wire
FDA 510(k) K213898 · Baylis Medical Company, Inc.
510(k) numberK213898
Submission
- Device name
- ProTrack Pigtail Wire
- Applicant
- Baylis Medical Company, Inc.
Mississauga, CA - Received
- December 14, 2021
- Decision date
- March 1, 2023
- 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 ProTrack Pigtail Wire cleared by the FDA?
ProTrack Pigtail Wire (K213898) received a 510(k) decision of Substantially Equivalent on March 1, 2023, 442 days after the submission was received.
What is the product code of K213898?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.