FDA 510(k) clearance · back to tracker

CATHETER, CARDIAC PACING, ENDOCARDIAL

American Technology, Inc. cleared K771528 on 1977-08-16, decision: substantially equivalent

K-number

K771528

Sponsor

American Technology, Inc.

Device

CATHETER, CARDIAC PACING, ENDOCARDIAL

Class

Class III

Decision

Substantially Equivalent

Decision date

1977-08-16

Product code

DTB

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.3680

Official FDA record

Open K771528on 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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Raw record →

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

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Drop K771528 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

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