Cleared Traditional

K982220 - MODEL 2872 BIPOLAR LEAD ADAPTOR KIT

K982220 is an FDA 510(k) clearance for MODEL 2872 BIPOLAR LEAD ADAPTOR KIT, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K982220 · Medtronic Vascular · Cardiovascular device
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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

FDA 510(k) Submission Details - K982220

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
Combination Product No
PCCP Authorized No
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.

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 96
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K982220.
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
K010787 · Oscor, Inc. · May 2001
A1-CS-SB Y-ADAPTER, MODEL 124 871
K003454 · Biotronik, Inc. · Jan 2001
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
K000210 · Medtronic Vascular · Feb 2000
A1-A,ABP,B,MBP, LEAD CONNECTORS
K970388 · Biotronik, Inc. · Aug 1997
BK-N SEALING CAP
K971930 · Biotronik, Inc. · Aug 1997
BK-A
K970204 · Biotronik, Inc. · Apr 1997