Primum Hydrophilic Guiding Catheter
FDA 510(k) K250972 · Pendracare
510(k) numberK250972
Submission
- Device name
- Primum Hydrophilic Guiding Catheter
- Applicant
- Pendracare
Leek, NL - Received
- March 31, 2025
- Decision date
- June 29, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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Questions and answers
When was Primum Hydrophilic Guiding Catheter cleared by the FDA?
Primum Hydrophilic Guiding Catheter (K250972) received a 510(k) decision of Substantially Equivalent on June 29, 2025, 90 days after the submission was received.
What is the product code of K250972?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.