SSPC NXT Delivery Catheter
FDA 510(k) K262240 · CenterPoint Systems, LLC
510(k) numberK262240
Submission
- Device name
- SSPC NXT Delivery Catheter
- Applicant
- CenterPoint Systems, LLC
West Valley City, UT, US - Received
- July 1, 2026
- Decision date
- July 29, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| K260559 | NHanceITDQY · Traditional | IMDS Operation B.V. | 08/14/2026SE |
| K262392 | APRO 35 Swift CatheterDQY · Special | Alembic, LLC | 08/12/2026SE |
| 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 |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB…DQY · Traditional | Medtronic, Inc. | 12/19/2025SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261766 | CPS Locator 3D Plus Delivery CatheterDQY · Special | 07/29/2026SE |
| K261492 | FieldFlex Steerable SheathDYB · Special | 06/05/2026SE |
| K260942 | AuST Steerable SheathDYB · Special | 04/07/2026SE |
| K260163 | AuST CSP IntroducerDYB · Special | 02/19/2026SE |
| K250147 | CPS Locator 3D Delivery CatheterDQY · Traditional | 08/22/2025SE |
| K250828 | CPS Locator 3D Plus Delivery CatheterDQY · Special | 06/27/2025SE |
| K250492 | FlexiGo 3D Delivery CatheterDQY · Special | 06/18/2025SE |
| K251051 | AuST Steerable SheathDYB · Special | 04/30/2025SE |
| K243180 | SSPC NXT Delivery CatheterDQY · Special | 12/04/2024SE |
| K242106 | AuST Steerable SheathDYB · Special | 10/04/2024SE |
Questions and answers
When was SSPC NXT Delivery Catheter cleared by the FDA?
SSPC NXT Delivery Catheter (K262240) received a 510(k) decision of Substantially Equivalent on July 29, 2026, 28 days after the submission was received.
What is the product code of K262240?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.