Cleared Traditional

K802175 - IMPLANTABLE VENTRICULAR-INHIBITED CARDI (FDA 510(k) Clearance)

K802175 · Telectronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1981
Decision
149d
Days
-
Risk

K802175 is an FDA 510(k) clearance for the IMPLANTABLE VENTRICULAR-INHIBITED CARDI.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1981 after a review of 149 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 Telectronics, Inc. devices

Submission Details

510(k) Number K802175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1980
Decision Date February 05, 1981
Days to Decision 149 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 125d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -