Cleared Special

K000210 - MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT

K000210 is an FDA 510(k) clearance for MODIFICATION TO MODEL 5866-37M LEAD ADA..., manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Special 510(k) pathway after a 30-day FDA review.

K000210 · Medtronic Vascular · Cardiovascular device
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Feb 2000
Decision
30d
Days
Class 2
Risk

K000210 is an FDA 510(k) clearance for the MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Medtronic Vascular (Shoreview, US). The FDA issued a Cleared decision on February 23, 2000 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K000210

510(k) Number K000210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received January 24, 2000
Decision Date February 23, 2000
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 102
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K000210.
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
K024156 · Oscor, Inc. · Jan 2003
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
K010787 · Oscor, Inc. · May 2001
A1-CS-SB Y-ADAPTER, MODEL 124 871
K003454 · Biotronik, Inc. · Jan 2001
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT
K982220 · Medtronic Vascular · Oct 1998
A1-A,ABP,B,MBP, LEAD CONNECTORS
K970388 · Biotronik, Inc. · Aug 1997
BK-N SEALING CAP
K971930 · Biotronik, Inc. · Aug 1997
K000210 · MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
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