Cleared Traditional

K870443 - KENZ-CARDICO 1201

K870443 · Suzuken Co., Ltd. · Cardiovascular device
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Jul 1987
Decision
148d
Days
-
Risk

K870443 is an FDA 510(k) clearance for the KENZ-CARDICO 1201.

Submitted by Suzuken Co., Ltd. (Culver City, US). The FDA issued a Cleared decision on July 1, 1987 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Suzuken Co., Ltd. devices

FDA 510(k) Submission Details - K870443

510(k) Number K870443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date July 01, 1987
Days to Decision 148 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 52
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