SSPC NXT Delivery Catheter— 510(k) K262240
Substantially EquivalentCenterPoint Systems, LLC
FDA 510(k) clearance K262240 for SSPC NXT Delivery Catheter, Substantially Equivalent on 2026-07-29. Applicant: CenterPoint Systems, LLC. Device class: 2.
Summary
CenterPoint Systems' SSPC NXT Delivery Catheter is filed under DQY, percutaneous catheters. The record doesn't expand "SSPC" or give the catheter's dimensions.
Class II, 21 CFR 870.1250. Cardiovascular is both the classification panel and the review panel, and it came in as a Special 510(k).
CenterPoint Systems filed from West Valley City, Utah. Review took 28 calendar days (July 1 to July 29, 2026).
Clearance details
- Applicant
- CenterPoint Systems, LLC
- Product code
- Product code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- West Valley City, UT, US
Recent devices under product code DQY
view allMore clearances from CenterPoint Systems, LLC
view allAdverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.