Cleared Traditional

K813518 - IMPLANT AID SPLICING CRIMP & SLEEVE (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K813518 · Intermedics, Inc. · Cardiovascular device
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Jan 1982
Decision
27d
Days
Class 3
Risk

K813518 is an FDA 510(k) clearance for the IMPLANT AID SPLICING CRIMP & SLEEVE. Classified as Materials, Repair Or Replacement, Pacemaker (product code KFJ), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1982 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3710 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. 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 Intermedics, Inc. devices

Submission Details

510(k) Number K813518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1981
Decision Date January 12, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KFJ Materials, Repair Or Replacement, Pacemaker
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3710
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.