510(k) K261242
K261242 is an FDA 510(k) premarket notification submitted by Pendracare for the device "SimplGuide". The FDA issued a decision of Substantially Equivalent on Jun 25, 2026. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Pendracare has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 25, 2026
- Date Received
- Apr 15, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type
- 510(k)