FineCross M3
FDA 510(k) K203521 · Ashitaka Factory of Terumo Corporation
510(k) numberK203521
Submission
- Device name
- FineCross M3
- Applicant
- Ashitaka Factory of Terumo Corporation
Fujinomiya, JP - Received
- December 1, 2020
- Decision date
- March 3, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K170223 | ProgreatDQO · Traditional | 07/21/2017SE |
| K161546 | R2P SlenGuideDQY · Traditional | 10/14/2016SE |
| K152740 | Radifocus GlidewireDQX · Traditional | 11/16/2015SE |
| K150232 | Radifocus Optitorque Angiographic CatheterDQO · Traditional | 10/19/2015SE |
| K130520 | Capiox FX15 and FX25 Hollow Fiber Oxygenator/ReservoirDTZ · Special | 03/13/2013SE |
Questions and answers
When was FineCross M3 cleared by the FDA?
FineCross M3 (K203521) received a 510(k) decision of Substantially Equivalent on March 3, 2021, 92 days after the submission was received.
What is the product code of K203521?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.