SimplGuide— 510(k) K261242
Substantially EquivalentPendracare
FDA 510(k) clearance K261242 for SimplGuide, Substantially Equivalent on 2026-06-25. Applicant: Pendracare. Device class: 2.
Summary
SimplGuide from Pendracare is filed under DYB, catheter introducers. The record gives no model numbers, sizes, or description beyond the name.
Class II, 21 CFR 870.1340. Cardiovascular is both the classification panel and the review panel. The submission was a Traditional 510(k).
Pendracare filed from Leek, Netherlands. Review took 71 calendar days (April 15 to June 25, 2026).
Clearance details
- Applicant
- Pendracare
- Product code
- Product code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leek, NL
Recent devices under product code DYB
view allMore clearances from Pendracare
view allAdverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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.