Cleared Traditional

K770478 - ADAPTER

K770478 is an FDA 510(k) clearance for ADAPTER, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K770478 · Cordis Corp. · Cardiovascular device
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Mar 1977
Decision
19d
Days
Class 2
Risk

K770478 is an FDA 510(k) clearance for the ADAPTER, CORDIS. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1977 after a review of 19 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 Cordis Corp. devices

FDA 510(k) Submission Details - K770478

510(k) Number K770478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1977
Decision Date March 30, 1977
Days to Decision 19 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
106d faster than avg
Panel avg: 125d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTD Device Classification - Class 2, Special Controls

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 86
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K770478.
LEAD ADAPTOR KIT MODEL 5866-21
K772058 · Medtronic Vascular · Nov 1977
UNIVERSAL LEAD ADAPTER, UA-414
K771641 · Pacesetter Systems · Sep 1977
ADAPTER A-413
K771642 · Pacesetter Systems · Sep 1977
LEAD EXTENDER MODEL 6516
K770199 · Cardiac Pacemakers, Inc. · Feb 1977
ADAPTER, LEAD, GENERAL ELECTRIC
K770042 · Cardiac Pacemakers, Inc. · Jan 1977