Cleared Traditional

K982220 - MODEL 2872 BIPOLAR LEAD ADAPTOR KIT (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K982220 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
113d
Days
Class 2
Risk

K982220 is an FDA 510(k) clearance for the MODEL 2872 BIPOLAR LEAD ADAPTOR KIT. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 15, 1998 after a review of 113 days - within the typical 510(k) review window.

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: 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 Medtronic Vascular devices

Submission Details

510(k) Number K982220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received June 24, 1998
Decision Date October 15, 1998
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
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.