510(k) K250972
K250972 is an FDA 510(k) premarket notification submitted by Pendracare for the device "Primum Hydrophilic Guiding Catheter". The FDA issued a decision of Substantially Equivalent on June 29, 2025. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Pendracare has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2025
- Date Received
- March 31, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type