FDA 510(k) clearance · back to tracker

Bioptimal Bipolar Pacing Catheter

Bioptimal International Pte. , Ltd. cleared K242863 on 2025-06-15, decision: substantially equivalent

K-number

K242863

Sponsor

Bioptimal International Pte. , Ltd.

Device

Bioptimal Bipolar Pacing Catheter

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-06-15

Product code

LDF

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.3680

Official FDA record

Open K242863on accessdata.fda.gov →

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

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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.