FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ProTrack Pigtail Wire
K Number: K213898
·
Decision Mar 1, 2023
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
24
Review Days
442
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Basic Information
- Device Name
- ProTrack Pigtail Wire
- K Number
- K213898
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baylis Medical Company, Inc.
- Date Received
- December 14, 2021
- Decision Date
- March 1, 2023
- Product Code
- DQX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Baylis Medical Company, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251325 | VersaCross Connect Transseptal Dilator | May 29, 2025 | Substantially Equivalent |
| K241720 | VersaCross Connect Transseptal Dilator | Jul 12, 2024 | Substantially Equivalent |
| K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath | Dec 20, 2023 | Substantially Equivalent |
| K233647 | VersaCross Connect Transseptal Dilator | Dec 14, 2023 | Substantially Equivalent |
| K221351 | Mechanical Guidewire | Dec 19, 2022 | Substantially Equivalent |
| K213582 | Epicardial Access System | Jun 30, 2022 | Substantially Equivalent |
| K220414 | VersaCross Connect Transseptal Dilator | May 9, 2022 | Substantially Equivalent |
| K201288 | ExpanSure Large Access Transseptal Dilator | Jun 12, 2020 | Substantially Equivalent |
| K191546 | Epicardial Access System | Aug 2, 2019 | Substantially Equivalent |
| K183632 | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable | Jun 7, 2019 | Substantially Equivalent |