Plato 17 Microcatheter
FDA 510(k) K210601 · Scientia Vascular, LLC
510(k) numberK210601
Submission
- Device name
- Plato 17 Microcatheter
- Applicant
- Scientia Vascular, LLC
West Valley City, UT, US - Received
- March 1, 2021
- Decision date
- April 28, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Other 510(k)s with product code DQY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260559 | NHanceITDQY · Traditional | IMDS Operation B.V. | 08/14/2026SE |
| K262392 | APRO 35 Swift CatheterDQY · Special | Alembic, LLC | 08/12/2026SE |
| K262240 | SSPC NXT Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261766 | CPS Locator 3D Plus Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY · Special | Abbott | 07/02/2026SE |
| K261631 | Amplatzer TorqVue Exchange SystemDQY · Special | Abbott Medical | 06/17/2026SE |
| K260289 | Perfect-O Ostial Positioning CatheterDQY · Traditional | Balosmark, Inc. | 06/05/2026SE |
| K260993 | Amplatzer TorqVue Delivery SystemDQY · Special | Abbott | 04/24/2026SE |
| K253361 | Teleport Glide MicrocatheterDQY · Traditional | OrbusNeich Medical (Shenzhen) Co., Ltd. | 04/10/2026SE |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/…DQY · Special | Abbott Medical | 03/13/2026SE |
More from Abbott Medical
| 510(k) | Device | Decision |
|---|---|---|
| K260223 | Aristotle Mini GuidewireMOF · Traditional | 08/06/2026SE |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter)NRY · Traditional | 07/16/2026SE |
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…MOF · Traditional | 04/29/2026SE |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…MOF · Special | 04/01/2025SE |
| K242301 | Socrates 38 CatheterQJP · Traditional | 12/04/2024SE |
| K223913 | Socrates Aspiration SystemNRY · Traditional | 09/20/2023SE |
| K223560 | Plato 17 MicrocatheterQJP · Traditional | 08/21/2023SE |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 GuidewireMOF · Special | 08/01/2023SE |
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14…MOF · Special | 03/10/2023SE |
| K222437 | Aristotle Colossus GuidewireMOF · Traditional | 01/26/2023SE |
Questions and answers
When was Plato 17 Microcatheter cleared by the FDA?
Plato 17 Microcatheter (K210601) received a 510(k) decision of Substantially Equivalent on April 28, 2021, 58 days after the submission was received.
What is the product code of K210601?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.