FDA 510(k) clearance · back to tracker

Primum Hydrophilic Guiding Catheter

Pendracare cleared K250972 on 2025-06-29, decision: substantially equivalent

K-number

K250972

Sponsor

Pendracare

Device

Primum Hydrophilic Guiding Catheter

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-06-29

Product code

DQY

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1250

Official FDA record

Open K250972on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.