FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Plato 17 Microcatheter
K Number: K210601
·
Decision Apr 28, 2021
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
10
Review Days
58
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Plato 17 Microcatheter
- K Number
- K210601
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scientia Vascular, LLC
- Date Received
- March 1, 2021
- Decision Date
- April 28, 2021
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQY), ordered by most recent decision date.
Amplatzer TorqVue Exchange System
FDA 510(k)
FDA Class 2
·Cardiovascular
Perfect-O Ostial Positioning Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer TorqVue Delivery System
FDA 510(k)
FDA Class 2
·Cardiovascular
Teleport Glide Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
FDA 510(k)
FDA Class 2
·Cardiovascular
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Scientia Vascular, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire | Mar 10, 2023 | Substantially Equivalent |
| K201760 | Zoom 14 Guidewire | Jul 29, 2020 | Substantially Equivalent |
| K192783 | Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile | Oct 30, 2019 | Substantially Equivalent |
| K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile | Mar 22, 2019 | Substantially Equivalent |
| K181828 | Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile | Aug 7, 2018 | Substantially Equivalent |
| K173235 | Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile | Jan 22, 2018 | Substantially Equivalent |
| K170406 | Plato MICROCATH 27B Microcatheter | Apr 18, 2017 | Substantially Equivalent |
| K143398 | Plato MICROCATH 27B Microcatheter | Jun 26, 2015 | Substantially Equivalent |
| K121734 | PLATO MICROCATH 27 MICROCATHETER | Jul 30, 2012 | Substantially Equivalent |