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FDA Tracker

Every catheter 510(k), the day FDA posts it.

Live from openFDA. Refreshed daily. Free, no account, no rate limit. Drop any clearance into Compass as a predicate candidate when you have a tenant.

Ablation Catheter Surgical Imaging Diagnostic All medical devices

All classes Class I Class II Class III3 entries · live · openFDA

510(k)

Sponsor

Device

Class

Cleared

Schneider Intl., Ltd.

SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER

Critikon Company, LLC

INIVOX ELECTRODE/CATHETER SYS

American Technology, Inc.

CATHETER, CARDIAC PACING, ENDOCARDIAL

live · openFDA · refreshed daily

Want this dataset, AI-summarized?

Compass turns these into substantial-equivalence tables.

Pick three predicates from this list, paste their K-numbers into Compass, and get a draft SE comparison against your device in under a minute. The same RIG that powers the agent above.

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