Cleared Traditional

K771642 - ADAPTER A-413

K771642 is the FDA 510(k) clearance for ADAPTER A-413 by Pacesetter Systems. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K771642 · Pacesetter Systems · Cardiovascular device
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Sep 1977
Decision
16d
Days
Class 2
Risk

K771642 is an FDA 510(k) clearance for the ADAPTER A-413. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on September 14, 1977 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pacesetter Systems devices

Submission Details

510(k) Number K771642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1977
Decision Date September 14, 1977
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTD Pacemaker Lead Adaptor

All 84
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K771642.
ADAPTER KIT
K781864 · Daig Corp. · Dec 1978
LEAD ADAPTOR KIT MODEL 5866-21
K772058 · Medtronic Vascular · Nov 1977
UNIVERSAL LEAD ADAPTER, UA-414
K771641 · Pacesetter Systems · Sep 1977
ADAPTER, CORDIS
K770478 · Cordis Corp. · Mar 1977
LEAD EXTENDER MODEL 6516
K770199 · Cardiac Pacemakers, Inc. · Feb 1977
ADAPTER, LEAD, GENERAL ELECTRIC
K770042 · Cardiac Pacemakers, Inc. · Jan 1977