Cleared Traditional

K770776 - TRAY, PRESSURE, INTRACOMPARTMENTAL,WICK (FDA 510(k) Clearance)

K770776 · Cutter Laboratories, Inc. · Cardiovascular device
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Aug 1977
Decision
98d
Days
-
Risk

K770776 is an FDA 510(k) clearance for the TRAY, PRESSURE, INTRACOMPARTMENTAL,WICK.

Submitted by Cutter Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1977 after a review of 98 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 Cutter Laboratories, Inc. devices

Submission Details

510(k) Number K770776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1977
Decision Date August 04, 1977
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -