ISAAC Neurovascular Navigation Catheter
FDA 510(k) K222115 · MicroVention, Inc.
510(k) numberK222115
Submission
- Device name
- ISAAC Neurovascular Navigation Catheter
- Applicant
- MicroVention, Inc.
Aliso Viejo, CA, US - Received
- July 18, 2022
- Decision date
- January 10, 2023
- 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 |
|---|---|---|
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01)JCX · Traditional | 06/13/2025SE |
| K232542 | Wedge XL Delivery CatheterQJP · Traditional | 05/16/2024SE |
| K230775 | SOFIA EX Intracranial Support CatheterQJP · Traditional | 09/14/2023SE |
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)NTE · Traditional | 04/27/2023SE |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)KRD · Traditional | 12/21/2022SE |
| K214024 | SOFIA 88 CatheterDQY · Traditional | 09/12/2022SE |
| K211120 | ERIC Retrieval DeviceNRY · Traditional | 03/31/2022SE |
| K193607 | BOBBY Balloon Guide CatheterDQY · Traditional | 07/21/2020SE |
| K201487 | Traxcess 7 Mini GuidewireMOF · Special | 07/02/2020SE |
| K200547 | Traxcess 14 SELECT GuidewireMOF · Special | 04/16/2020SE |
Questions and answers
When was ISAAC Neurovascular Navigation Catheter cleared by the FDA?
ISAAC Neurovascular Navigation Catheter (K222115) received a 510(k) decision of Substantially Equivalent on January 10, 2023, 176 days after the submission was received.
What is the product code of K222115?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.