Cleared Traditional

K772058 - LEAD ADAPTOR KIT MODEL 5866-21

K772058 is the FDA 510(k) clearance for LEAD ADAPTOR KIT MODEL 5866-21 by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K772058 · Medtronic Vascular · Cardiovascular device
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Nov 1977
Decision
3d
Days
Class 2
Risk

K772058 is an FDA 510(k) clearance for the LEAD ADAPTOR KIT MODEL 5866-21. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on November 3, 1977 after a review of 3 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 Medtronic Vascular devices

Submission Details

510(k) Number K772058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1977
Decision Date November 03, 1977
Days to Decision 3 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
122d faster than avg
Panel avg: 125d · This submission: 3d
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 K772058.
ELECTRODE, MODEL 030-324/4 GUAGE
K781824 · Telectronics, Inc. · Feb 1979
ELECTRODE LEAD MODEL 030-198
K782097 · Telectronics, Inc. · Dec 1978
ADAPTER KIT
K781864 · Daig Corp. · Dec 1978
UNIVERSAL LEAD ADAPTER, UA-414
K771641 · Pacesetter Systems · Sep 1977
ADAPTER A-413
K771642 · Pacesetter Systems · Sep 1977
ADAPTER, CORDIS
K770478 · Cordis Corp. · Mar 1977